Important Safety Information

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. 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). 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 proton pump inhibitor (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. Low magnesium levels can happen in some people who take a PPI medicine. The most common side effects of DEXILANT were diarrhea (4.8%), stomach pain (4.0%), nausea (2.9%), common cold (1.9%), vomiting (1.6%), and gas (1.6%). 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.

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

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.

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Low occurrence
of side effects

The most common side effects were diarrhea, stomach pain, nausea, common cold, vomiting, and gas.

DEXILANT has a low occurrence of side effects

Studies of more than 4500 people showed that DEXILANT had a low occurrence of side effects. The most common side effects were diarrhea, stomach pain, nausea, common cold, vomiting, and gas.

As you can see, the most common side effects affected a low percentage of patients in clinical studies.

Side Effects - Clinical Study Results


Side Effect

Placebo
(Sugar Pill)

(n=896)

DEXILANT
30 mg

(n=455)

DEXILANT
60 mg

(n=2218)

DEXILANT
Total

(n=2621)

Diarrhea

2.9%

5.1%

4.7%

4.8%

Stomach Pain

3.5%

3.5%

4.0%

4.0%

Nausea

2.6%

3.3%

2.8%

2.9%

Common Cold

0.8%

2.9%

1.7%

1.9%

Vomiting

0.8%

2.2%

1.4%

1.6%

Gas

0.6%

2.6%

1.4%

1.6%

n=the number of patients in each treatment group

What you should tell your doctor before and while
you take DEXILANT

Tell your doctor about all your medical conditions. Be sure to tell your doctor if you:

  • Have been told that you have low magnesium levels in your blood

  • Have liver problems

  • Have any other medical conditions

  • Are pregnant or plan to become pregnant

  • Are breastfeeding or planning to breastfeed

  • Have a vitamin B12 deficiency

Tell your doctor about all your medicines, including any prescription and any nonprescription medicines, herbal remedies, and vitamins. DEXILANT and certain other medicines can affect each other.

Before taking DEXILANT, 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.

How to take DEXILANT

Both DEXILANT doses (30 mg and 60 mg) are available in capsule form. You should take DEXILANT exactly as it was prescribed and for the full length of time. You can take DEXILANT with or without food. Capsules should be swallowed whole. If you have trouble swallowing DEXILANT capsules whole, you can open the capsules and sprinkle the contents on a tablespoon of applesauce. Be sure to swallow the applesauce mixture right away. Do not chew the mixture and do not store it for later use. As with other medications, be sure to take DEXILANT exactly as it was prescribed and for the full
length of time.

Important Safety Information

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. 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). 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 proton pump inhibitor (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. Low magnesium levels can happen in some people who take a PPI medicine. The most common side effects of DEXILANT were diarrhea (4.8%), stomach pain (4.0%), nausea (2.9%), common cold (1.9%), vomiting (1.6%), and gas (1.6%). 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.

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

Persistent heartburn two or more days a week, despite treatment and diet changes, could be gastroesophageal reflux disease (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 (called erosive esophagitis or EE), and for up to 6 months to continue healing of EE and relief of heartburn. Most damage (erosions) heals in 4–8 weeks. Individual results may vary.

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

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.

*Must meet Eligibility Requirements. This savings card covers out-of-pocket expenses greater than $20, up to a maximum benefit of $55 for a 30-day prescription or $165 for a commercially insured 90-day prescription.