What is the most important information I should know about RALDESY?

RALDESY can cause serious side effects, including:

 • Increased risk of suicidal thoughts or actions.RALDESY and other antidepressant medicines increase the risk of suicidal thoughts and actions in people 24 years of age and younger, especially within the first few months of     treatment or when the dose is changed. RALDESY is not for use in children.

     ◦ Depression and other mental illnesses are the most important causes of suicidal thoughts and actions.

      How can I watch for and try to prevent suicidal thoughts and actions?

      ◦ Pay close attention to any changes, especially sudden changes in mood, behaviors, thoughts, or feelings if you develop suicidal thoughts or actions. This is very important when an antidepressant medicine is started or when           the dose is changed.

      ◦ Call your healthcare provider right away to report new or sudden changes in mood, behavior, thoughts or feelings, or if you develop suicidal thoughts or actions.

      ◦ Keep all follow-up visits with your healthcare provider as scheduled. Call your healthcare provider between visits as needed, especially if you are worried about symptoms.

 • attempts to commit suicide                                                • acting on dangerous impulses             • acting aggressive or violent

 • thoughts about suicide or dying                                         • new or worse depression                     • a new or worse anxiety or panic attacks

 • feeling agitated, restless, angry, or irritable                       • trouble sleeping                                   • an increase in activity or talking more than what is normal for you

 • other unusual changes in behavior and mood

See “What are the possible side effects of RALDESY?”for more information about side effects.

What is RALDESY?

RALDESY is a prescription medicine used in adults to treat major depressive disorder (MDD).

It is not known if RALDESY is safe and effective for use in children.

Who should not take RALDESY?

Do not take RALDESY if you:

 • are taking, or have stopped taking within the last 14 days, a medicine called Monoamine Oxidase Inhibitor (MAOI), including the antibiotic linezolid and intravenous methylene blue

Ask your healthcare provider or pharmacist is you are not sure if you take an MAOI, including the antibiotic linezolid or intravenous blue.

Do not start taking an MAOI for at least 14 days after you stop treatment with RALDESY.

Before taking RALDESY tell your healthcare provider about all of your medical conditions, including if you:

 • have or have a family history of heart problems, including fast or slow heartbeat, or changes in the electrical activity of your heart (QT prolongation)

 • have ever had a heart attack

 • have or have had bleeding problems

 • are male and have conditions that may cause a prolonged or painful erection (priapism) such as sickle cell anemia, multiple myeloma, leukemia, or a deformed penis

 • have or have a family history of bipolar disorder, mania, or hypomania

 • have high pressure in the eye (glaucoma)

 • have low sodium levels in your blood

 • are pregnant or plan to become pregnant. It is not known if RALDESY will harm your unborn baby. Talk to your healthcare provider about the risks to you or your unborn baby if you take RALDESY during pregnancy.

     ◦ Tell your healthcare provider right away if you become pregnant or think you are pregnant during treatment with RALDESY.

     ◦ There is a pregnancy registry for females who are exposed to RALDESY during pregnancy. The purpose of this registry is to collect information about the health of females exposed to RALDESY and their baby.
        If you become pregnant during treatment with RALDESY, talk to your healthcare provider about registering with the National Pregnancy Registry for Antidepressants. You can register by calling 1-866-961-2388 or visiting         online at https://womensmentalhealth.org/research/pregnancyregistry/antidepressants/.

 • are breastfeeding or plan to breastfeed. RALDESY passes into your breast milk. Talk to your healthcare provider about the best way to feed your baby during treatment with RALDESY.

Tell your healthcare provider about all the medicines you take, including prescription and over-the-counter medicines, vitamins, and herbal supplements.

RALDESY and some other medicines may affect each other causing serious side effects. RALDESY may affect the way other medicines work and other medicines may affect the way RALDESY works.

Especially tell your healthcare provider if you take:

 • MAOIs

 • medicines used to treat migraine headache called triptans

 • medicines used to treat mood, anxiety, psychotic or thought disorders, including tricyclic antidepressants, lithium, selective serotonin reuptake inhibitors (SSRIs), serotonin and norepinephrine reuptake inhibitors (SNRIs),    buspirone, or antipsychotics

 • tramadol, fentanyl, or other opioids

 • over-the-counter supplements such as tryptophan or St. John’s Wort

 • medicines used to treat high blood pressure

 • medicines used to treat irregular heartbeats

 • medicines that affect blood clotting such as aspirin, nonsteroidal anti-inflammatory drugs (NSAIDS), warfarin or other blood thinners

 • digoxin

 • medicines used to treat seizures or convulsions

 • diuretics

Ask your healthcare provider if you are not sure if you are taking any of these medicines. Your healthcare provider can tell you if it is safe to take RALDESY with your other medicines.

Do notstart or stop any other medicines during treatment with RALDESY without talking to your healthcare provider first. Stopping RALDESY suddenly may cause you to have serious side effects. See, “What are the possible side effects of RALDESY?”

Know the medicines you take. Keep a list of them to show it to your healthcare provider and pharmacist when you get a new medicine.

How should I take RALDESY?

See the detailed Instructions for Use that comes with RALDESY for information on how to take RADELSY oral solution.

 • Take RALDESY exactly as your healthcare provider tells you. Your healthcare provider may need to change your dose of RALDESY until it is the right dose for you.

 • If you feel sleepy after taking RALDESY, talk to your healthcare provider. Your healthcare provider may change your dose or the time of day you take your RALDESY.

 • Take RALDESY after a meal or light snack.

 • Do not stop taking RALDESY without talking to your healthcare provider.

 • If you take too much RALDESY, call your healthcare provider, your Poison Help Line at 1-800-222-1222, or go to the nearest hospital emergency room right away.

What should I avoid while taking RALDESY?

 • Do notdrive, operate heavy machinery, or do other dangerous activities until you know how RALDESY affects you. RALDESY can cause sleepiness or may affect your ability to make decisions, think clearly, or react quickly.

 • Do notdrink alcohol or take other medicines that make you sleepy or dizzy during treatment with RALDESY until you talk with your healthcare provider. RALDESY may make your sleepiness or dizziness worse if you drink     alcohol or take other medicines that cause sleepiness or dizziness.

What are the possible side effects of RALDESY?

RALDESY can cause serious side effects, including:

 • See “What is the most important information I should know about RALDESY?”

Serotonin syndrome. A potentially life-threating problem called serotonin syndrome can happen when you take RALDESY with certain other medicines. See “Who should not take RALDESY?” Call your healthcare provider or go to the nearest hospital emergency room right awayif you have any of the following signs and symptoms of serotonin syndrome:

       ◦ agitation                                                                                            ◦ flushing

       ◦ seeing or hearing things that are not real (hallucinations)               ◦ high body temperature (hyperthermia)

       ◦ confusion                                                                                          ◦ shaking (tremors), stiff muscles, or muscle twitching

       ◦ coma                                                                                                 ◦ loss of coordination

       ◦ fast heartbeat                                                                                    ◦ seizures

       ◦ changes in blood pressure                                                                ◦ nausea, vomiting, diarrhea

       ◦ sweating                                                                                           ◦ dizziness

 • Changes in the electrical activity of your heart (QT prolongation).Call your healthcare provider right away if you have any of the following symptoms: abnormal heartbeats, dizziness, feel lightheaded or faint.

 • Low blood pressure and fainting.Low blood pressure can happen when you change positions from sitting to standing or laying down. You may feel dizzy, lightheaded, or faint.

 • Increased risk of bleeding.Taking RALDESY with aspirin, non-steroidal anti-inflammatory drugs (NSAIDs), warfarin, or blood thinners may add to this risk. Tell your healthcare provider right away about any unusual    bleeding or bruising.

 • Painful erection lasting for more than 6 hours (priapism).If you have an erection that lasts more than 4 hours, get medical help right away.

 • Manic episodes.Manic episodes may happen in people with bipolar disorder who take RALDESY. Symptoms may include:

       ◦ greatly increased energy                          ◦ severe problems sleeping

       ◦ racing thoughts                                        ◦ reckless behavior

       ◦ unusually grand ideas                             ◦ excessive happiness or irritability

       ◦ talking more or faster than usual

 • Discontinuation syndrome.Suddenly stopping RALDESY may cause you to have serious side effects. Your healthcare provider may want to decrease your dose slowly. Symptoms may include:

         ◦ nausea                                 ◦ electric shock feeling (paresthesia)              ◦ tiredness

         ◦ sweating                             ◦ tremor                                                            ◦ problems sleeping

         ◦ changes in your mood        ◦ anxiety                                                           ◦ hypomania

         ◦ irritability and agitation      ◦ confusion                                                       ◦ ringing in the ears (tinnitus)

         ◦ dizziness                             ◦ headache                                                         ◦ seizures

 • Eye problems (angle-closure glaucoma).RALDESY can cause a type of eye problem called angle-closure glaucoma in people with certain eye conditions. You may want to undergo an eye examination to see if you are at risk     and receive preventative treatment if you are. Call your healthcare provider if you have changes in your vision, eye pain, or swelling or redness in or around the eye.

 • Low sodium in your blood (hyponatremia).Low sodium levels in your blood that may be serious and may cause death, can happen during treatment with RALDESY. Elderly people and people who take certain medicines may     be at greater risk for this. Signs and symptoms may include:

       ◦ headache                                                              ◦ confusion

       ◦ difficulty concentrating                                       ◦ weakness and unsteadiness on your feet, which can lead to falls

       ◦ memory changes

       ◦ talking more or faster than usual

In more severe or sudden cases, signs and symptoms include:

       ◦ seeing or hearing things that are not real                          ◦ coma

         (hallucinations)                                                                  ◦ stopping breathing (respiratory arrest) to falls

       ◦ fainting

       ◦ seizures

The most common side effects of RALDESY include:

       • swelling                        • tiredness

       • blurred vision               • diarrhea

       • fainting                         • stuffy nose

       • sleepiness                     • weight loss

These are not all of the possible side effects of RALDESY.

Call your doctor for medical advice about side effects. You may report side effects to FDA at 1-800 FDA-1088.

How should I store RALDESY?

 • Store RALDESY at room temperature between 68°F to 77°F (20°C to 25°C).

 • RALDESY comes in a bottle with a child-resistant cap.

 • Keep RALDESY out of the light.

 • Throw away (discard) RALDESY 20 days after first opening the bottle.

 • Safely throw away medicine that is out of date or no longer needed.

Keep RALDESY and all medicines out of the reach of children

General information about the safe and effective use of RALDESY.

Medicines are sometimes prescribed for purposes other than those listed in a Medication Guide. Do not use RALDESY for a condition for which it was not prescribed. Do not give RALDESY to other people, even if they have the same symptoms that you have. It may harm them. You can ask your pharmacist or healthcare provider for information about RALDESY that is written for health professional.