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Prevacid Prescribing Information


PREVACID®
(lansoprazole)


Complete prescribing information


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Once-daily prescription Prevacid is approved for GERD in children aged 1-17 years. Individual results may vary.

Important Safety Information

Prevacid Capsules and Prevacid SoluTab (lansoprazole) Orally Disintegrating Tablets are not for everyone. Your child should not take Prevacid if they are allergic to Prevacid or any of its ingredients. Prevacid has a low occurrence of side effects in adults and children. The most frequently reported adverse events in patients aged 1 to 11 years were constipation (5%) and headache (3%). In patients aged 12 to 17 years, the most frequently reported adverse events were headache (7%), abdominal pain (5%), nausea (3%), and dizziness (3%). The adverse event profile in children and adolescents resembled that of adults taking Prevacid, where the most common adverse events were diarrhea (3.8%), abdominal pain (2.1%) and nausea (1.3%). Symptom relief does not rule out other serious stomach conditions. Before using Prevacid, tell your child’s doctor if they are taking ampicillin, atazanavir, digoxin, iron, ketoconazole, theophylline, tacrolimus or warfarin. If your child is taking Prevacid with warfarin, they may need to be monitored because serious risks could occur.

Please see the accompanying complete prescribing information for Prevacid and talk with your child’s healthcare provider.

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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Prevacid® is a registered trademark of Takeda Pharmaceuticals North America, Inc., and is used under license by Takeda Pharmaceuticals America, Inc.