About ZULRESSO
ZULRESSO safety information and side effects
ZULRESSO® (brexanolone) may cause serious side effects that you should be aware of.
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About ZULRESSO
ZULRESSO® (brexanolone) may cause serious side effects that you should be aware of.
Excessive sedation and sudden loss of consciousness. ZULRESSO may cause you to feel very sleepy (excessive sedation) or pass out (loss of consciousness) during treatment. Your healthcare provider should check you for symptoms of excessive sleepiness every 2 hours while you are awake.
Because of the risk of serious harm resulting from excessive sedation or sudden loss of consciousness, ZULRESSO is only available through a restricted program called the ZULRESSO Risk Evaluation and Mitigation Strategy (REMS).
Increased risk of suicidal thoughts or actions. ZULRESSO and other antidepressant medicines may increase suicidal thoughts and actions in some people 24 years of age and younger. Depression or other serious mental illnesses are the most significant causes of suicidal thoughts or actions.
The side effects that were most common among individuals who took ZULRESSO were:
These are not all the side effects of ZULRESSO. For more information, speak with your healthcare provider.
Because of the risk of serious harm resulting from extreme sleepiness (excessive sedation) or passing out (loss of consciousness) during treatment, mothers will be monitored by a healthcare provider in a healthcare setting.
Speak with your healthcare provider if you experience any side effects or have any questions, or to learn if ZULRESSO is right for you.
Before receiving ZULRESSO, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
ZULRESSO and some medicines may interact with each other and cause serious side effects.
Especially tell your healthcare provider if you take:
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider will decide if other medicines can be taken with ZULRESSO.
What else to know about ZULRESSO: ZULRESSO may make you feel dizzy and sleepy. Do not drive a car or do other dangerous activities after your ZULRESSO infusion until your feeling of sleepiness has completely gone away. Do not drink alcohol while receiving ZULRESSO.
ZULRESSO® is a prescription medicine used to treat Postpartum Depression in individuals 15 years and older.
It is not known if ZULRESSO is safe and effective in individuals less than 15 years of age.
ZULRESSO can cause serious side effects, including:
Before receiving ZULRESSO, tell your healthcare provider about all your medical conditions, including if you:
Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.
ZULRESSO and some medicines may interact with each other and cause serious side effects.
Especially tell your healthcare provider if you take other antidepressants, opioids, or Central Nervous System (CNS) depressants (such as benzodiazepines).
Know the medicines you take. Keep a list of them to show your healthcare provider and pharmacist when you get a new medicine. Your healthcare provider will decide if other medicines can be taken with ZULRESSO.
ZULRESSO is given to you by continuous intravenous (IV) infusion into your vein. The infusion will last for a total of 60 hours (2.5 days).
ZULRESSO can cause serious side effects, including:
How can I watch for and try to prevent suicidal thoughts and actions?
Tell your healthcare provider right away if you have any of the following symptoms, especially if they are new, worse, or worry you:
The most common side effects of ZULRESSO include:
These are not all the side effects of ZULRESSO.
Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800-FDA-1088.
Please also see Full Prescribing Information including Boxed Warning and Medication Guide for ZULRESSO® and discuss any questions you may have with your healthcare provider.
ZULRESSO® (brexanolone) is a prescription medicine used to treat Postpartum Depression in individuals 15 years and older.
IMPORTANT SAFETY INFORMATION
ZULRESSO can cause serious side effects, including: Excessive sedation and sudden loss of consciousness. ZULRESSO may cause you to feel very sleepy (excessive sedation) or pass out (loss of consciousness). Your healthcare provider should check you for symptoms of excessive sleepiness every 2 hours while you are awake