From the Guidelines
Dexilant (dexlansoprazole) can cause several side effects, including common issues like headache, diarrhea, abdominal pain, nausea, and flatulence, as well as less common but more serious problems such as severe diarrhea, vitamin B12 deficiency, low magnesium levels, and bone fractures with prolonged use. According to the study published in Pediatrics 1, Dexilant is not indicated for pediatric use, and its side effects profile is similar to other proton pump inhibitors (PPIs). The study also notes that PPIs, in general, are considered safe and well-tolerated, but can cause adverse effects such as headaches, diarrhea, constipation, and nausea in up to 14% of older children and adults 1.
Some key points to consider when taking Dexilant include:
- Common side effects: headache, diarrhea, abdominal pain, nausea, and flatulence
- Less common but more serious side effects: severe diarrhea, vitamin B12 deficiency, low magnesium levels, bone fractures with prolonged use, and kidney inflammation
- Long-term use associated with increased risk of stomach polyps, fundic gland polyps, and potentially increased risk of certain infections due to reduced stomach acid
- Importance of monitoring for severe or persistent side effects and contacting a healthcare provider if necessary
It's essential to weigh the potential benefits of Dexilant against its potential side effects, particularly in pediatric patients, where its use is not indicated 1. As with any medication, it's crucial to follow the prescribed dosage and consult with a healthcare provider if concerns arise. The American Academy of Pediatrics guidelines strike a note of caution when discussing the dramatic increase in PPI prescriptions for pediatric patients, particularly infants, who may be at increased risk of lower respiratory tract infections 1.
From the FDA Drug Label
The most common adverse reactions (≥2%) that occurred at a higher incidence for dexlansoprazole capsules than placebo in the controlled studies are presented in Table 2 Table 2: Common Adverse Reactions in Controlled Studies in Adults Adverse Reaction Placebo (N=896) % Dexlansoprazole capsules 30 mg (N=455) % Dexlansoprazole capsules 60 mg (N=2,218) % Dexlansoprazole capsules Total (N=2,621) % Lansoprazole 30 mg (N=1,363) % Diarrhea 2.9 5.1 4.7 4.8 3.2 Abdominal Pain 3.5 3.5 4 4 2.6 Nausea 2.6 3.3 2.8 2.9 1.8 Upper Respiratory Tract Infection 0.8 2.9 1.7 1.9 0. 8 Vomiting 0.8 2.2 1.4 1.6 1.1 Flatulence 0.6 2.6 1.4 1.6 1.2 The most common side effects of dexlansoprazole delayed-release capsules in adults include: diarrhea stomach pain nausea common cold vomiting gas The most common side effects of dexlansoprazole delayed-release capsules in children 12 to 17 years of age include: headache stomach pain diarrhea pain or swelling (inflammation) in your mouth, nose or throat
The side effects of dexilant include:
- Gastrointestinal: diarrhea, abdominal pain, nausea, vomiting, flatulence
- Respiratory: upper respiratory tract infection
- Other: headache, common cold, gas, pain or swelling (inflammation) in your mouth, nose or throat These side effects are based on data from clinical trials and postmarketing experience 2, 2.
From the Research
Side Effects of Dexilant
- The most common side effects of proton pump inhibitors, such as lansoprazole, include diarrhea, headache, and abdominal pain, which occur in approximately 3% of patients and are reversible with drug discontinuation 3.
- Dexlansoprazole, a new-generation proton pump inhibitor, has a good safety profile and carries a low risk of adverse interactions with other drugs 4.
- Studies have shown that dexlansoprazole is well tolerated compared to placebo or lansoprazole, with no significant differences in rates of adverse events 5.
- The dual delayed-release formulation of dexlansoprazole provides two distinct releases of medication, prolonging the mean residence time compared to lansoprazole, which may contribute to its safety profile 5.
- Dexlansoprazole has been shown to achieve good plasma concentration regardless of administration with food, providing flexible dosing, and has no clinically important effects on exposure to the active metabolite of clopidogrel or clopidogrel-induced platelet inhibition 6.