How safe is Diclegis®?

The FDA rates Diclegis® as Pregnancy Category A, the highest safety rating possible.

  • Diclegis® is the only FDA-approved medication specifically designed to help manage morning sickness symptoms throughout pregnancy when diet and lifestyle changes don’t work.
  • Pregnancy Category A means that studies in pregnant women have shown that this medicine does not present an increased risk to the baby.*
  • The combination of antihistamine and vitamin B6 in Diclegis® is one of the most studied drug combinations in pregnancy, including in the first trimester.
  • The drug combination in Diclegis® is recommended by both the American College of Obstetricians and Gynecologists (ACOG) and the Association of Professors of Gynecology and Obstetrics (APGO), when diet and lifestyle changes don’t work.
  • Diclegis® may cause drowsiness. Its safety and efficacy has not been established in children under 18 years of age.
  • Women should not take Diclegis® while breastfeeding. 

Talk to your healthcare provider about Diclegis® today!


* You should still talk to your healthcare provider about any potential risk.

Important Safety Information and Indication

Indication

Diclegis® is a prescription medicine used to treat nausea and vomiting of pregnancy in women who have not improved with change in diet or other non-medicine treatments.

Limitations of Use

Diclegis® has not been studied in women with hyperemesis gravidarum.

Important Safety Information

Do not take Diclegis® if you are allergic to doxylamine succinate, other ethanolamine derivative antihistamines, pyridoxine hydrochloride or any of the ingredients in Diclegis®. You should also not take Diclegis® in combination with medicines called monoamine oxidase inhibitors (MAOIs), as these medicines can intensify and prolong the adverse central nervous system (CNS) effects of Diclegis®.

The most common side effect of Diclegis® is drowsiness. Do not drive, operate heavy machinery, or other activities that need your full attention unless your healthcare provider says that you may do so.

Do not drink alcohol, or take other CNS depressants such as cough and cold medicines, certain pain medicines, and medicines that help you sleep while you take Diclegis®. Severe drowsiness can happen or become worse causing falls or accidents.

Diclegis® should be used with caution in women who have certain medical conditions, such as asthma, or eye, stomach or bladder problems. Tell your healthcare provider about all of your medical conditions so he/she can assess if Diclegis® is right for you.

It is not known if Diclegis® is safe and effective in children under 18 years of age. Keep Diclegis® and all medicines out of the reach of children.

Diclegis® is a multilayer, extended release formulation, so signs of overdose may not appear right away. If you take too much Diclegis® (overdose), you may have the following symptoms: restlessness, dry mouth, the pupils of your eyes become larger (dilated), sleepiness, dizziness, confusion, fast heart rate, seizures, muscle pain or weakness, and sudden and severe kidney problems. If you have these symptoms and they are severe, they may lead to death. Stop taking Diclegis®, call your healthcare provider or go to the nearest hospital emergency room right away. For more information about overdose treatment, call your poison control center at 1-800-222-1222.

Diclegis® is intended for use in pregnant women.

Tell your healthcare provider about all of your medical conditions, including if you are breastfeeding or plan to breastfeed. Diclegis® can pass into your breast milk and may harm your baby. You should not breastfeed while using Diclegis®.

Duchesnay USA encourages you 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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