How safe is Diclegis®?

How safe is Diclegis®?

Diclegis® has been designed with the Safety of Mother and Baby in mind.

Diclegis® has been studied in pregnant women.

Diclegis® has a Pregnancy Category A status, the best rating available.

Diclegis® PillEach Diclegis® tablet shows a pregnant woman because it was created for you.

 

Pregnancy CategoryDefinition
A Studies in pregnant women have shown that the medicine does not present an increased risk to the baby.*

* You should still speak to your healthcare provider about any potential risks.

 

Understanding FDA Pregnancy Categories

The FDA created pregnancy letter categories to help explain what is known about using medicine during pregnancy. The FDA chooses a medicine's letter category based on what is known about the medicine when used in pregnant women and animals. The letter category is listed in the label of a prescription medicine. The label states whether studies were done in pregnant women or pregnant animals and if so, what happened.

 

Tablet(s) shown are not actual size.

Important Safety Information

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 delayed-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.

For additional important safety information, please see full Prescribing and Patient Information. This information is not intended to replace discussions with your healthcare provider.