Rexulti (brexpiprazole)

Rexulti is a brand-name prescription drug. It’s approved by the Food and Drug Administration (FDA) to treat:

• Major depressive disorder (MDD). This condition is also called depression. For MDD, doctors can prescribe Rexulti, in combination with an antidepressant, for adults.
• Schizophrenia. For schizophrenia, doctors can prescribe Rexulti for adults and children ages 13 years and older.

For more information about these conditions and how the drug is used to treat them, see the “Rexulti: Uses” section below.

This table provides key facts about Rexulti.

If you’re interested in taking this drug, search here to find a doctor who might prescribe it.

Rexulti contains the active drug brexpiprazole. It only comes as a brand-name medication. And it isn’t currently available as a generic drug.

Generics are identical copies of the active drug in a brand-name medication. Generics typically cost less than brand-name drugs.

As with most drugs, it’s possible to have side effects with Rexulti. These can include some mild side effects, but also some serious ones.

To learn more about Rexulti’s side effects, talk with your doctor or pharmacist. They may also provide information about managing certain side effects of this drug.

Note: The Food and Drug Administration (FDA) tracks side effects of drugs it has approved. If you would like to notify the FDA about a side effect you’ve had with Rexulti, you can do so through MedWatch.

Mild and serious side effects of Rexulti are listed in the table below. This table does not include all of Rexulti’s possible side effects.

* This is not a complete list of Rexulti’s mild side effects. To learn about other mild side effects of this drug, ask your doctor or pharmacist. Or you can view the drug’s prescribing information.
† For more information about this side effect, see “Rexulti’s side effects explained” below.
‡ Rexulti has a boxed warning Trusted Source PubMed Central Highly respected database from the National Institutes of Health Go to source for this side effect. This is the most serious warning from the FDA. To learn more, see “Rexulti’s side effects explained” below.

Most times, mild side effects of a drug go away within a few days or a couple of weeks. Talk with your doctor or pharmacist if any side effects become severe or don’t go away.

Serious side effects from Rexulti aren’t common, but they are possible. If you have serious side effects, call your doctor right away. However, if you’re having a medical emergency or your symptoms feel life threatening, call 911 or a local emergency number.

Below, you can find detailed information about some of Rexulti’s side effects. To learn more about other side effects of this medication, talk with your doctor.

Antipsychotic drugs can increase the risk of death when taken by adults ages 65 years and older with psychosis related to dementia. (Psychosis is a mental health condition that causes delusions or hallucinations.) Keep in mind that Rexulti is an antipsychotic.

In fact, Rexulti has a boxed warning Trusted Source PubMed Central Highly respected database from the National Institutes of Health Go to source for this risk. A boxed warning is the most serious warning from the Food and Drug Administration (FDA). It alerts doctors and patients about drug effects that may be dangerous.

In clinical studies of antipsychotics, the most common causes of death in older people were related to:

• heart problems
• infections, such as pneumonia

Additionally, antipsychotics can increase the risk of stroke in older people with psychosis related to dementia. And in some cases, having a stroke can lead to death. Symptoms of stroke can include:

• confusion
• headache
• weakness in your leg, arm, or face (usually on one side of your body)
• trouble seeing, speaking, or walking

Tell your doctor right away if you have symptoms of stroke while taking Rexulti.

Due to these risks, doctors typically won’t prescribe Rexulti for adults ages 65 years and older who have psychosis related to dementia. If you’re an older adult with these conditions, talk with your doctor. They can advise on the treatment option that’s best for you.

Drugs used to treat depression can increase the risk of suicidal thoughts and behaviors in some people. And keep in mind that Rexulti is used to treat depression.

In fact, Rexulti has a boxed warning Trusted Source PubMed Central Highly respected database from the National Institutes of Health Go to source for this risk. A boxed warning is the most serious warning from the FDA. It alerts doctors and patients about drug effects that may be dangerous.

The risk is high in children and young adults ages 24 years or younger. Regardless of age, the risk also affects people who’ve recently started taking Rexulti or had their dosage changed.

Doctors may monitor for new or worsening suicidal thoughts or behaviors while you’re taking Rexulti. They’ll likely also watch for changes in your mood, such as anger, hostility, irritability, and agitation. Tell your doctor if you have any of these symptoms during treatment with this drug.

If you have thoughts of harming yourself while taking Rexulti, call 911 or your local emergency number right away.

Suicide prevention

If you think someone is at immediate risk of self-harm or hurting another person:

• Call 911 or your local emergency number.
• Stay with the person until help arrives.
• Remove any guns, knives, medications, or other things that may cause harm.
• Listen, but don’t judge, argue, threaten, or yell.

If you or someone you know is considering suicide, get help from a crisis or suicide prevention hotline. Try the National Suicide Prevention Lifeline at 800-273-8255.

Weight gain is a common side effect of antipsychotic drugs, including Rexulti. To learn more about how often this side effect occurred in clinical studies, see the drug’s prescribing information.

Weight gain with Rexulti may happen because of changes in your body’s metabolism. (“Metabolism” describes the chemical processes that keep your body functioning.) If your metabolism is slowed with Rexulti, you may have weight gain.

If you have bothersome weight gain while taking Rexulti, talk with your doctor. They can recommend healthy ways to manage your weight while you’re taking Rexulti.

Here are some common questions about Rexulti and brief answers to them. If you’d like to know more about these topics, ask your doctor.

Yes, Rexulti has some similarities to Abilify, Latuda, Vraylar, and Seroquel.

All of these drugs are approved to treat schizophrenia. And Rexulti, Abilify, and Seroquel are also used to treat depression. However, these medications have other uses as well. To learn about schizophrenia and how Rexulti treats it, see the “Rexulti: Uses” section.

To learn more about how Rexulti compares with Abilify, Latuda, Vraylar, and Seroquel, talk with your doctor.

Rexulti isn’t currently approved to treat bipolar disorder or intrusive thoughts.

Bipolar disorder is a mental health condition that causes extreme changes in mood and energy levels. Intrusive thoughts are bothersome thoughts that enter your head suddenly.

However, doctors sometimes prescribe Rexulti off-label for these conditions. With off-label use, doctors prescribe a drug for a purpose other than what it’s approved for.

If you’re interested in using Rexulti for bipolar disorder or intrusive thoughts, talk with your doctor. They can recommend the best treatment for your condition.

Rexulti isn’t currently approved to treat anxiety. However, doctors sometimes prescribe Rexulti off-label for this condition. With off-label use, doctors prescribe a drug for a purpose other than what it’s approved for.

Keep in mind that Rexulti may cause new or worsened anxiety as a side effect. If you have worsened anxiety with Rexulti, your doctor may advise that you stop taking the drug.

If you have anxiety, talk with your doctor. They can suggest the best treatment for your condition. If your doctor prescribes this drug for anxiety, they’ll recommend the dosage of Rexulti that’s right for you.

No, Rexulti isn’t likely to cause weight loss, hair loss, or mania. (Mania refers to periods of extremely high energy and excitement, often related to bipolar disorder.) These weren’t reported as side effects in clinical studies of Rexulti.

In fact, Rexulti is more likely to cause weight gain than weight loss. For details about weight gain with Rexulti, see “Rexulti’s side effects explained” in the “Rexulti: Side effects” section above.

Talk with your doctor if you’re concerned about weight loss, hair loss, or mania with Rexulti.

No, Rexulti isn’t an antidepressant or a type of antidepressant called a selective serotonin reuptake inhibitor (SSRI). Instead, Rexulti belongs to a group of drugs called atypical antipsychotics. (This is a group of newer antipsychotic drugs.)

However, like antidepressants, Rexulti is used to treat depression. When it’s prescribed for depression, Rexulti is used in combination with antidepressants such as SSRIs. Sertraline (Zoloft) is an example of an SSRI that may be used with Rexulti.

If you’d like to know more about taking an antidepressant with Rexulti, ask your doctor.

No, taking Rexulti isn’t likely to make you feel “high” (euphoric). This side effect wasn’t reported in clinical studies of the drug.

If you’re concerned about feeling high after taking Rexulti, talk with your doctor.

Below, you’ll find dosages that are commonly recommended for Rexulti. However, you should take the dosage your doctor prescribes for you. They’ll recommend the dosage that’s best for your needs.

Most often, doctors start by prescribing a low dosage of Rexulti. Then, they’ll change the dosage over time to a dosage range that’s right for the condition being treated. Doctors typically prescribe the smallest dosage that gives the desired outcome.

The dosage of Rexulti that your doctor prescribes will depend on several factors, such as:

• your age
• any health conditions you have
• other medications you take
• the condition you’re using Rexulti to treat and the severity of the condition

Rexulti is available as follows:

• Form: oral tablet
• Strengths: 0.25 milligrams (mg), 0.5 mg, 1 mg, 2 mg, 3 mg, and 4 mg

Recommended dosages for Rexulti in adults and children are described below.

Rexulti is approved to treat depression and schizophrenia in adults.

Rexulti’s recommended dosage for depression in adults is as follows:

• Starting dosage: 0.5 mg to 1 mg once daily
• Maintenance dosage: 2 mg once daily
• Maximum dosage: 3 mg once daily

Rexulti’s recommended dosage for schizophrenia in adults is as follows:

• Starting dosage: 1 mg once daily
• Maintenance dosage: 2 mg to 4 mg once daily
• Maximum dosage: 4 mg once daily

Your doctor may prescribe a different dosage of Rexulti depending on several factors, including whether or not you have kidney or liver problems. If you have questions about the dosage that’s right for you, talk with your doctor.

Rexulti is approved to treat schizophrenia in children ages 13 years and older.

Rexulti’s recommended dosage for schizophrenia in children is as follows:

• Starting dosage: 0.5 mg once daily
• Maintenance dosage: 2 mg to 4 mg once daily
• Maximum dosage: 4 mg once daily

Below are some things to consider about Rexulti’s dosage.

Missing a dose. If you miss a dose of Rexulti, take your missed dose as soon as you remember. However, if it’s almost time for your next dose, skip your missed dose. Then, take your next dose at its usual time. Don’t take any extra doses to make up for a missed dose. Doing this can increase your risk of side effects. (For information on side effects, see the “Rexulti: Side effects” section above.)

View these medication reminder options to help avoid missing doses. You could also set an alarm, use a timer, or download a reminder app on your phone.

Length of treatment. Doctors typically prescribe Rexulti as a long-term treatment. You’ll likely take it long term if you and your doctor feel it’s safe and effective for your condition.

Prescription drugs, such as Rexulti, are approved by the Food and Drug Administration (FDA) to treat certain conditions. Doctors sometimes prescribe drugs off-label for other conditions. With off-label use, doctors prescribe a drug for a purpose other than what it’s approved for.

Rexulti is approved to treat major depressive disorder (MDD) in adults. (MDD is commonly known as depression.)

Doctors typically diagnose depression if any of the following symptoms are present almost daily for at least 2 weeks:

• weight loss or weight gain
• loss of appetite
• loss of interest in activities that used to be enjoyable
• changes in mood
• trouble sleeping or sleeping more than usual

For this use, doctors prescribe Rexulti in combination with an antidepressant.

Rexulti is approved to treat schizophrenia in adults and children ages 13 years and older.

Doctors typically diagnose schizophrenia if two or more of the symptoms below are present for at least 1 month:

• delusions (believing things that aren’t real) or hallucinations (seeing or hearing things that aren’t real)
• disorganized behaviors, such as being unable to coordinate your muscle movements or being extremely agitated
• loss of focus or interest in school, work, or other activities

When used to treat depression, Rexulti is taken in combination with an antidepressant. Below are examples of antidepressants that doctors may prescribe with Rexulti:

• vortioxetine (Trintellix)
• duloxetine (Cymbalta)
• sertraline (Zoloft)
• escitalopram (Lexapro)

Your doctor will determine which drug combination is best for treating your condition.

Rexulti is approved to treat schizophrenia in adults and children ages 13 years and older. For details about this condition, see “Using Rexulti for schizophrenia” above.

If you’re interested in taking Rexulti, you can find a doctor who might prescribe it by searching here. You can prepare for your appointment by visiting Healthgrades’ appointment guide for depression or schizophrenia.

Like other medications, prices for Rexulti may vary. The drug’s price will depend on factors such as:

• the pharmacy you use
• your insurance coverage

Here’s a list of things to consider when looking into the cost of Rexulti.

• Option for a 90-day supply. For some drugs, it’s possible to get a 90-day supply. If this option is approved by your insurance company, it can help lower the cost of the drug. It can also help you avoid frequent trips to your pharmacy. If you’d like to learn more about this option, ask your doctor, pharmacist, or insurance company.
• Need for prior authorization. Before insurance coverage for Rexulti is approved, your insurance company may require prior authorization. In this case, your doctor and insurance company will communicate about your prescription for Rexulti. Then, the insurance company will decide if the drug will be covered. To find out if you need prior authorization for Rexulti, contact your insurance company.
• Possible cost assistance options. Financial assistance to help lower the cost of Rexulti is available. Otsuka America Pharmaceutical, Inc., the manufacturer of the drug, offers a copay card for Rexulti. To learn more about this copay card, call 844-415-0674 or visit the manufacturer’s website. Also, check out this article to learn about ways to save on prescription drugs. If you don’t have commercial insurance, you may find cost assistance for Rexulti through this program.
• Use of a mail-order pharmacy. Rexulti may be dispensed through mail-order pharmacies. Getting your prescription through a mail-order pharmacy could lower its cost. It can also allow you to get the drug without leaving home. To find out more about this option, check with your doctor, pharmacist, or insurance company.
• Availability of a generic form. Rexulti doesn’t come in a generic form. A generic drug is an exact copy of the active drug in a brand-name medication. Typically, generics cost less than brand-name drugs.

Rexulti is approved to treat the mental health conditions below.

• Major depressive disorder (MDD). MDD is also known as depression. It causes symptoms such as mood changes, trouble sleeping, and loss of appetite.
• Schizophrenia. Schizophrenia causes symptoms such as delusions, hallucinations, and disorganized behaviors.

To learn how Rexulti is used for these conditions, see the “Rexulti: Uses” section above.

Rexulti belongs to a group of drugs called atypical antipsychotics. (This is a group of newer antipsychotic drugs.)

Rexulti’s mechanism of action (the way it works) isn’t completely understood. It’s thought to increase levels of brain chemicals called dopamine and serotonin. Having higher levels of these chemicals in the body can help ease symptoms of depression and schizophrenia.

After starting Rexulti, it may take several weeks for you to notice the symptoms of your condition beginning to ease.

Rexulti likely stays in your system for about 3 weeks.

This is based on Rexulti’s half-life. (A drug’s half-life is the amount of time it takes your body to get rid of half of a drug’s dose.) Rexulti’s half-life is about 86 to 91 hours. This means it takes about 86 to 91 hours for your body to get rid of half of a dose of Rexulti.

It usually takes about five half-lives for your body to get rid of a drug completely. For Rexulti, this means the drug stays in your system for about 18 to 19 days.

Studies of Rexulti haven’t shown that the drug causes dependence. (Dependence happens when your body needs a drug to function like usual.)

Drugs that cause dependence will typically cause withdrawal symptoms after you stop taking the drug. However, these symptoms weren’t reported in studies of Rexulti.

That said, it’s important that you don’t stop taking Rexulti without talking with your doctor. They can help determine if it’s best for you to keep taking Rexulti or stop your treatment. If you and your doctor decide that you’ll stop taking Rexulti, they’ll help you stop the drug safely.

There aren’t any known interactions between Rexulti and alcohol.

However, it’s important to note that drinking alcohol with Rexulti can worsen certain side effects of the drug. This includes sleepiness.

If you drink alcohol, ask your doctor if it’s safe to do so while you’re taking Rexulti.

Rexulti may interact with other medications. However, it’s not known to interact with any herbs, supplements, or foods.

Different interactions can cause different effects. Some interactions can interfere with a drug’s effectiveness. Others can increase a drug’s side effects or cause them to be severe.

If any of the interactions listed below might pertain to you, talk with your doctor. They can tell you what you need to do to avoid the interaction.

• Rexulti and other medications. Because Rexulti may interact with the following drugs, your doctor may recommend that you don’t take it with these drugs. Examples include:
  • certain antifungals, such as fluconazole (Diflucan)
  • certain antidepressants, such as bupropion (Wellbutrin SR, Wellbutrin XL) and paroxetine (Paxil)
  • certain antibiotics, such as clarithromycin (Biaxin XL) and rifampin (Rifadin)
  • certain seizure medications, such as phenytoin (Dilantin) and carbamazepine (Carbatrol, Tegretol)
• Rexulti and herbs and supplements. No herbs or supplements have been reported to interact with Rexulti. Check with your doctor or pharmacist before using any of these products while taking Rexulti.
• Rexulti and foods. Rexulti isn’t known to interact with any foods. If you have questions about eating certain foods with Rexulti, talk with your doctor or pharmacist.

Doctors may prescribe drugs other than Rexulti for depression and schizophrenia. Certain drugs may work better for you than others.

Rexulti is used to treat depression in combination with an antidepressant. Here’s a summary of other drugs that doctors sometimes prescribe for depression. In some cases, these drugs are used instead of Rexulti. In other cases, they may be used with Rexulti.

To learn more about alternatives to Rexulti, ask your doctor. They can tell you about other medications that could be prescribed for your condition.

Unwanted side effects or overdose can occur by taking more than the recommended dosage of certain drugs.  Do not take more Rexulti than your doctor recommends.

Call your doctor if you think you’ve taken too much of this drug. Also, you can call the American Association of Poison Control Centers at 800-222-1222 or use their online tool. However, if your symptoms are severe, call 911 or your local emergency number. Or go to the nearest emergency room right away.

Your doctor will tell you how you should take Rexulti. It’s important that you take the drug exactly as your doctor instructs.

Rexulti comes as an oral tablet.

Here’s a list of common questions related to taking Rexulti.

• When should I take Rexulti? You’ll likely take Rexulti once per day. View these medication reminder options to help avoid missing doses. You could also set an alarm, use a timer, or download a reminder app on your phone.
• Do I need to take Rexulti with food? You can take Rexulti with or without food.
• Can Rexulti be chewed, split, or crushed? The manufacturer of Rexulti doesn’t state whether or not the tablets can be chewed, split, or crushed. If you have trouble swallowing Rexulti tablets, talk with your doctor or pharmacist.
• Is there a best time of day to take Rexulti? No, there isn’t a best time of day to take Rexulti. You can take the drug any time of day. However, try to take your doses around the same time each day. This helps keep a steady level of Rexulti in your body, allowing the drug to work well.

It isn’t known if Rexulti is safe to take while pregnant.

Clinical studies haven’t looked at the use of Rexulti during pregnancy. However, there have been reports of side effects in infants born to people who took antipsychotic drugs during their last 3 months of pregnancy. (Keep in mind that Rexulti is an antipsychotic.)

Examples of these side effects include:

• increased or decreased muscle tone
• sleepiness
• trouble breathing
• tremors
• trouble eating or refusing to eat certain foods
• agitation (feeling bothered or restless)

If you use Rexulti during pregnancy, consider participating in the National Pregnancy Registry for Psychiatric Medications. This registry collects information about the effects of antipsychotic drugs when taken during pregnancy. Your doctor can give you more information about this pregnancy registry. You can also visit the registry’s website or call 866-961-2388.

If you’re pregnant or planning to become pregnant, talk with your doctor about the risks and benefits of using Rexulti during pregnancy.

Doctors aren’t sure if it’s safe to take Rexulti during pregnancy. Ask your doctor about your birth control needs with Rexulti if you’re sexually active and you or your partner can become pregnant. Your doctor can determine if you should use birth control while taking this drug.

It’s not known if Rexulti passes into breast milk. So, it isn’t known if the drug affects children who are breastfed.

If you’re breastfeeding or planning to do so, talk with your doctor before taking Rexulti. They can suggest healthy ways to feed your child while taking Rexulti.

This drug comes with several precautions.

This drug has boxed warnings Trusted Source PubMed Central Highly respected database from the National Institutes of Health Go to source , the most serious warnings from the Food and Drug Administration (FDA). Boxed warnings alert doctors and patients about drug effects that may be dangerous.

Increased risk of death in certain people. Doctors typically won’t prescribe Rexulti for adults ages 65 years and older who have psychosis related to dementia. (Psychosis is a mental health condition that causes delusions or hallucinations.) This is because antipsychotic drugs can increase the risk of death when taken by older adults with psychosis related to dementia. And keep in mind that Rexulti is an antipsychotic drug.

Increased risk of suicidal thoughts and behaviors. Drugs used to treat depression can increase the risk of suicidal thoughts and behaviors in some people. And Rexulti is used to treat depression in certain people. This risk is high in children and young adults ages 24 years or younger. Regardless of age, the risk also affects people who’ve recently started taking Rexulti or had their dosage changed. Doctors will monitor for new or worsening suicidal thoughts or behaviors while you’re taking Rexulti.

Tell your doctor about your health history before starting treatment with Rexulti. Your doctor may not recommend this medication if you have certain factors affecting your health or specific medical conditions.

These factors and conditions include those listed below.

• Kidney or liver problems. Tell your doctor if you have kidney or liver problems. They may prescribe a lower dosage of Rexulti for you than usual.
• Seizures. Rexulti may cause seizures. Before taking this drug, tell your doctor if you have seizures now or if you’ve had them in the past. Your doctor will determine whether it’s safe for you to take Rexulti.
• Diabetes. Rexulti may cause changes in your metabolism that result in high blood sugar levels. (“Metabolism” describes the chemical processes that keep your body functioning.) Before starting Rexulti, tell your doctor if you have diabetes. They may have you check your blood sugar more often than usual while you’re taking Rexulti.
• Heart problems. Tell your doctor about any heart problems you have before starting Rexulti. Especially tell them if you have a history of heart attack or heart failure. This is because Rexulti can cause orthostatic hypotension (sudden drop in blood pressure upon standing). Your risk of this side effect may be higher if you already have heart problems. Your doctor can tell you if it’s safe to take Rexulti.
• Cholesterol problems. Rexulti may cause changes in your metabolism that result in high cholesterol and triglyceride levels. Before starting Rexulti, tell your doctor if you already have cholesterol problems. They’ll likely watch your cholesterol more closely than usual while you’re taking Rexulti.
• Allergic reaction. Your doctor will likely not prescribe Rexulti If you’ve had an allergic reaction to it or any of its ingredients. To find out about other treatment options, talk with your doctor.
• Pregnancy. It’s not known for sure if Rexulti is safe to take during pregnancy. If you’d like to learn more information about taking Rexulti while pregnant, view the “Rexulti and pregnancy” section above.
• Breastfeeding. It isn’t known if Rexulti passes into breast milk. If you’d like to learn more about taking Rexulti while breastfeeding, view the “Rexulti and breastfeeding” section above.

To learn more about effects of Rexulti that could be harmful, see the “Rexulti: Side effects” section above.

Here’s some information about Rexulti’s expiration date, as well as how to store and dispose of the drug.

• Expiration. Your pharmacist will add an expiration date to the label on Rexulti’s bottle. This date is usually 1 year from the date the medication was dispensed to you. Expiration dates help ensure that a medication is effective during a period of time. The Food and Drug Administration (FDA) Trusted Source Food and Drug Administration (FDA) Governmental authority Go to source advises that you avoid using expired drugs. If you have an unused medication and it’s past the drug’s expiration date, talk with your pharmacist. They can let you know whether you might still be able to use the medication.
• Storage. Many factors determine how long a medication remains good to use. These factors include how and where you store the drug. Rexulti tablets should be stored at room temperature between 68°F and 77°F (20°C and 25°C). The drug can temporarily be stored at temperatures between 59°F and 86°F (15°C and 30°C), such as when traveling. Avoid storing it in areas where it could get damp or wet, such as bathrooms. The medication should be kept away from light in a tightly sealed container.
• Disposal. It’s important to safely dispose of Rexulti if you no longer need to take it and have unused medication. Doing so helps prevent others, including children and pets, from accidentally taking the drug. It also helps avoid causing harm to the environment. Ask your pharmacist for information about disposing of Rexulti. Also, check out this page for several tips on safe medication disposal.

If you have questions about Rexulti, talk with your doctor. They can advise you on whether the drug could be a good treatment option for your condition. Here’s a list of questions you may want to ask your doctor.

• Do I have a higher risk of any side effects of Rexulti?
• Will Rexulti interact with any medications I’m taking?
• Do I have any health conditions that could affect how my body responds to Rexulti?

Your doctor may also tell you about other treatment options for your condition. You may find this article helpful in learning about alternative drugs for depression. And check out our selection of videos about depression.

Disclaimer: Healthgrades has made every effort to make certain that all information is factually correct, comprehensive, and up to date. However, this article should not be used as a substitute for the knowledge and expertise of a licensed healthcare professional. You should always consult your doctor or another healthcare professional before taking any medication. The drug information contained herein is subject to change and is not intended to cover all possible uses, directions, precautions, warnings, drug interactions, allergic reactions, or adverse effects. The absence of warnings or other information for a given drug does not indicate that the drug or drug combination is safe, effective, or appropriate for all patients or all specific uses.