DEXILANT may not be right for everyone.

Do not take DEXILANT if you are allergic to DEXILANT or any of its ingredients or taking a medicine that contains rilpivirine.

Serious allergic reactions have been reported. Tell your doctor if you get any of the following symptoms with DEXILANT: rash, face swelling, throat tightness, or difficulty breathing. Symptom relief does not rule out other serious stomach conditions.

A type of kidney problem called acute tubulointerstitial nephritis may develop at any time during treatment with proton pump inhibitor (PPI) medicines, including DEXILANT. Call your doctor right away if you have a decrease in the amount that you urinate or if you have blood in your urine.

DEXILANT may increase your risk of getting severe diarrhea. Call your doctor right away if you have watery stool, stomach pain, and fever that does not go away.

People who are taking multiple daily doses of PPI medicines for a long period of time (a year or longer) may have an increased risk of fractures of the hip, wrist, or spine.

Some people who take PPIs may develop new or worsening of certain types of lupus erythematosus. Call your doctor right away if you have joint pain or rash on your cheeks or arms that gets worse in the sun.

Talk with your doctor about the possibility of Vitamin B-12 deficiency if you have been on DEXILANT for a long time (more than 3 years).

Low magnesium levels can happen in some people who take a PPI medicine for at least 3 months.

People who take PPI medicines for a long time (especially more than 1 year) have an increased risk of developing a certain type of stomach growth called fundic gland polyps.

DEXILANT is not recommended in children under 2 years of age and may harm them.

The most common side effects of DEXILANT in adults were diarrhea (4.8%), stomach pain (4.0%), nausea (2.9%), common cold (1.9%), vomiting (1.6%), and gas (1.6%).

The most common side effects in children 12 to 17 years of age were headache, stomach pain, diarrhea, and pain or swelling (inflammation) in your mouth, nose or throat.

Before starting DEXILANT, tell your doctor if you are pregnant or plan to become pregnant.

DEXILANT and certain other medicines can affect each other.

Tell your doctor about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements. Tell your doctor if you are taking methotrexate, rilpivirine, atazanavir, nelfinavir, saquinavir, digoxin, product containing iron, erlotinib, dasatinib, nilotinib, mycophenolate mofetil, ketoconazole/itraconazole, tacrolimus, St. John’s Wort or rifampin. If you are taking DEXILANT with warfarin, you may need to be monitored because serious risks could occur.

You are encouraged to report negative side effects of prescription drugs to the FDA. Visit www.fda.gov/medwatch or call 1-800-FDA-1088.

DEXILANT (dexlansoprazole) 30 mg and 60 mg delayed-release capsules

Prescription DEXILANT capsules are used in children age 12 to 17 years for 4 weeks to treat heartburn related to gastroesophageal reflux disease (GERD), for up to 8 weeks to heal acid-related damage to the lining of the esophagus (called erosive esophagitis or EE), and for up to 16 weeks to continue healing of EE and relief of heartburn. It is not known if DEXILANT is safe and effective in children under age 12 years. DEXILANT is not effective for symptoms of GERD in children under 1 year of age.

In adults, persistent heartburn two or more days a week, despite treatment and diet changes, could be GERD, also known as acid reflux disease (ARD). Prescription DEXILANT capsules are used in adults for 4 weeks to treat heartburn related to GERD, for up to 8 weeks to heal acid-related damage to the lining of the esophagus, and for up to 6 months to continue healing of EE and relief of heartburn. Most damage (erosions) heals in 4 to 8 weeks.

Individual results may vary.

Talk to your doctor or healthcare professional. Please see full Prescribing Information, including Medication Guide for DEXILANT.