Mayzent (siponimod) is a prescription drug that’s used to treat certain types of multiple sclerosis and clinically isolated syndrome. Mayzent comes as an oral tablet.
Mayzent is used in adults to treat:
- clinically isolated syndrome (CIS), which may be a beginning sign of multiple sclerosis (MS) but doesn’t always lead to MS
- relapsing-remitting MS (RRMS)
- active secondary progressive MS (SPMS)
To learn more about Mayzent’s uses, see the “Is Mayzent used for MS?” section below.
Mayzent basics
Mayzent contains the active ingredient siponimod. (An active ingredient is what makes a drug work.) It’s not available as a generic drug. Instead, it comes only as the brand-name drug Mayzent.
Mayzent comes as tablets that you’ll swallow.
Read on to learn more about Mayzent’s side effects, uses, and other key information.
Like most drugs, Mayzent may cause mild or serious side effects. The lists below describe some of the more common side effects that Mayzent may cause. These lists don’t include all possible side effects.
Keep in mind that side effects of a drug can depend on:
- your age
- other health conditions you have
- other medications you may be taking
Your doctor or pharmacist can tell you more about the potential side effects of Mayzent. They can also suggest ways to help reduce side effects.
Mild side effects
Here’s a short list of some of the mild side effects that Mayzent can cause. To learn about other mild side effects, talk with your doctor or pharmacist, or read Mayzent’s prescribing information.
Mild side effects of Mayzent that have been reported include:
- diarrhea
- nausea
- headache
- edema (swelling)*
Mild side effects of many drugs may go away within a few days to a couple of weeks. But if they become bothersome, talk with your doctor or pharmacist.
* For more information on this side effect, see the “Side effect focus” section below.
Serious side effects
Serious side effects from Mayzent can occur, but they aren’t common. If you have serious side effects from Mayzent, call your doctor right away. However, if you think you’re having a medical emergency, you should call 911 or your local emergency number.
Serious side effects of Mayzent that have been reported include:
- high blood pressure
- lung problems, such as trouble breathing and wheezing
- increased risk of skin cancer
- increased liver enzymes, which may indicate liver damage
- slow heart rate
- eye side effects, such as macular edema*
- infections,* such as progressive multifocal leukoencephalopathy (PML)
- allergic reaction*
* For more information on this side effect, see the “Side effect focus” section below.
Side effect focus
Learn more about some of the side effects Mayzent may cause.
Eye side effects
Mayzent may cause problems with your eyes, such as macular edema.
Macular edema causes fluid to build up in your macula, which is the center area of your retina. (The retina is the area in your eye that senses light.)
Symptoms of macular edema may include:
- changes in your vision, including double vision
- blurry vision
- changes to how you see color, such as seeing colors as being faded
What might help
Before you start treatment with Mayzent, you’ll need to have an eye exam, including an exam of your macula. You may also need eye exams during treatment with Mayzent if you have any vision changes.
Your doctor will discuss the benefits and risks of treatment with Mayzent, including whether you’re at risk of macular edema.
If you have diabetes or uveitis, you have a higher risk of macular edema with Mayzent. (Uveitis is swelling of your uvea, which is the middle layer in your eye.) If you have either of these conditions, your doctor may recommend more frequent eye checkups during Mayzent treatment.
Infections
Treatment with Mayzent may increase your risk of certain kinds of infections.
Infections can happen with Mayzent because the drug may weaken the activity of your immune system. And with lowered immunity, your body can’t fight infections as usual. In rare cases, some infections may be life threatening or fatal.
Common infections seen in people who took Mayzent during studies include:
An infection called progressive multifocal leukoencephalopathy (PML) may also be possible during Mayzent treatment. PML is a rare, aggressive viral infection that attacks the myelin sheath. (The myelin sheath is a protective layer that covers nerve fibers in your brain and spinal cord.)
What might help
Before you start treatment with Mayzent, your doctor will order blood tests to make sure you don’t have an infection. If you have a severe, active infection, your doctor may have you wait to start Mayzent until your infection clears.
Your doctor will also monitor you for signs of new infections for up to 4 weeks after you finish Mayzent treatment.
If you develop an infection during treatment with Mayzent, your doctor may have you stop taking Mayzent until your infection clears.
If you develop PML, your doctor will have you stop taking Mayzent. They will also likely monitor you after treatment ends for immune reconstitution inflammatory syndrome (IRIS). For people who experience PML, IRIS is a serious condition that can develop after stopping treatment with Mayzent and similar drugs.
Call your doctor right away if you have symptoms of an infection while taking Mayzent. These symptoms can include:
- fever
- rash
- trouble breathing
- fatigue (low energy)
- body aches and pains
If you have an infection, your doctor will recommend a treatment plan, and they’ll discuss with you the risks and benefits of using Mayzent. The earlier you start treatment for an infection, the sooner your infection may clear up.
Edema
It’s possible to have edema (swelling) during Mayzent treatment. In studies, people taking this drug had edema in their:
- legs and hands (a condition called peripheral edema)
- joints
- face
What might help
If you have swelling in your lower legs, arms, or face with Mayzent, call your doctor. They’ll make sure you’re not having an allergic reaction to the drug. (Swelling is a possible symptom of allergic reaction. See the section directly below for more details.)
Additionally, if you have edema, your doctor may order lab tests to check how well your heart, liver, and kidneys are working.
If your edema is mild, your doctor may suggest some lifestyle changes, such as:
- exercising
- elevating your arms and legs above the level of your heart to reduce swelling
- reducing your salt intake
- avoiding sitting or standing in one position for too long, and instead, taking breaks to walk around
If your edema is more serious or bothersome to you, your doctor may discuss other options to address it. And this could include using treatments other than Mayzent for your condition, if appropriate.
Allergic reactionSome people may have an allergic reaction to Mayzent.
Symptoms of a mild allergic reaction can include:
- skin rash
- itchiness
- flushing (temporary warmth, redness, or deepening of skin color)
A more severe allergic reaction is rare but possible. Symptoms of a severe allergic reaction can include swelling under your skin, typically in your eyelids, lips, hands, or feet. They can also include swelling of your tongue, mouth, or throat, which can cause trouble breathing.
Call your doctor right away if you have an allergic reaction to Mayzent. But if you think you’re having a medical emergency, call 911 or your local emergency number.
Find answers to some commonly asked questions about Mayzent.
Is Mayzent similar to either Gilenya or Ocrevus?
Mayzent, Gilenya, and Ocrevus are all used to treat certain types of multiple sclerosis (MS). These medications have some similarities and some differences in their uses, side effects, and dosage forms.
These three drugs haven’t been directly compared with each other in studies. But they’ve all been effective in separate studies for treating MS.
Mayzent, Gilenya, and Ocrevus each contain a different active ingredient. While Mayzent and Gilenya are both taken by mouth, Ocrevus is given as an injection into a vein. And Ocrevus is administered less often than Mayzent or Gilenya, which are taken each day.
To learn more about how Mayzent compares with Gilenya or Ocrevus, see a detailed comparison in this article. Be sure to talk with your doctor about which treatment option is right for you.
How does Mayzent work?
Mayzent’s exact mechanism of action (the way it works) isn’t clear.
With MS, which Mayzent is used to treat, the immune system attacks the myelin sheath. The immune system helps protect against infection and is made up of various components, including different types of white blood cells. And the myelin sheath is a protective layer that covers nerve fibers in the brain and spinal cord.
MS affects how your brain sends signals to other areas of your body. To learn more about MS, including its symptoms, see the “Is Mayzent used for MS?” section below.
It’s thought that Mayzent helps lower the level of certain white blood cells called lymphocytes in your brain and spinal cord. This may be how the drug helps to reduce MS symptoms.
How should Mayzent be stored?
Mayzent comes as tablets inside bottles and blister packs. Mayzent’s shelf-life (how long it remains good to use) depends on:
- how it’s stored
- where it’s stored
It’s important to keep medications, including Mayzent, stored according to their manufacturer’s recommendations. This way, the drug will work the way it’s supposed to for your condition.
You should store unopened bottles or blister packs of Mayzent at a room temperature of 68–77°F (20–25°C) for up to 3 months. If you need to store unopened containers of Mayzent for longer than 3 months, you should store the drug in a refrigerator and keep the temperature between 35–46°F (2–8°C).
Opened bottles or blister packs of Mayzent can be stored at room temperature for up to 3 months. If you were prescribed the blister pack, keep the tablets in the original blister pack until you are ready to take a dose.
After 3 months, you should throw away any unused Mayzent according to local guidelines on safe disposal of medications. (Talk with a pharmacist about these guidelines in your area.)
If you have more questions about storing Mayzent, talk with your doctor or pharmacist.
Will I need to have tests or exams before starting Mayzent?
Yes, before starting treatment with Mayzent, your doctor may order certain tests. These include:
- complete blood count (CBC) to check the levels of your blood cells
- liver function tests (LFTs) to check the health of your liver
- an eye exam to check your vision
- an electrocardiogram (EKG) to check how well your heart is working
- a skin exam to check for skin lesions (abnormal growths), as Mayzent may increase the risk of skin cancer
In addition, your doctor may order a varicella zoster virus (chickenpox) antibody test to check your immunity to the virus. Depending on the results of your antibody test, you may need to complete a varicella zoster vaccine series at least 4 weeks before starting treatment with Mayzent.
Your doctor will likely also check your blood to find out your genetic type of the enzyme CYP2C9. (Enzymes are certain types of proteins.) CYP2C9 helps break down medications in your body. Learning about the gene you have for this enzyme can help your doctor decide on the dose of Mayzent that’s right for you.
Additionally, when you first start taking Mayzent, your doctor may monitor your heart rate and blood pressure for 6 hours. They’ll do this to make sure the drug is safe for you to take. You may need further monitoring after the initial 6 hours to make sure your heart rate doesn’t drop too low after taking Mayzent.
Your doctor may also order other tests if needed. Talk with your doctor to find out more information about the tests and monitoring you’ll need with Mayzent treatment.
Costs of prescription drugs can vary depending on many factors. These factors include what your insurance plan covers and which pharmacy you use.
If you have questions about how to pay for your prescription, talk with your doctor or pharmacist. You can also visit the Mayzent manufacturer’s website to see whether it has support options that you are eligible for.
If you have multiple sclerosis (MS), your doctor may discuss Mayzent as a treatment option for you. It’s a prescription drug that’s used in adults to treat certain types of MS and clinically isolated syndrome (CIS).
Specifically, Mayzent is approved to treat the following conditions:
- CIS. With CIS, you have an episode of demyelination (damage to the lining of your nerves). CIS may be an early sign of MS. But it doesn’t always lead to MS. With CIS, you have a single episode of MS-like symptoms.
- Relapsing-remitting MS (RRMS). RRMS is the most common type of MS. With RRMS, you have cycles of remission (absence of MS symptoms) and relapse (return of MS symptoms).
- Active secondary progressive MS (SPMS). SPMS is the stage of MS that can happen after RRMS. With SPMS, you’re no longer in remission. Instead, you have active MS symptoms or flare-ups of MS symptoms.
MS is a long-lasting condition that affects your nervous system. It causes problems with how your central nervous system, which is made up of your brain and spinal cord, communicates with the rest of your body.
With MS, the immune system, which protects against infection, is overactive, and it attacks and damages the myelin sheath. (The myelin sheath is a protective layer that covers nerve fibers in your brain and spinal cord.) This leads to issues with brain signals communicating with the rest of your body.
Symptoms of MS include:
- problems with balance
- bladder issues, such as urinary frequency or urgency, and loss of bladder control
- trouble thinking clearly
- muscle spasms, stiffness, and pain
- sexual dysfunction
- tingling and numbness in your arms and legs or one side of your face or trunk
- vision problems
- tiredness or weakness
Mayzent treats CIS, RRMS, and SPMS by lowering the activity of your immune system. For more information, see “How does Mayzent work?” in the “What are some frequently asked questions about Mayzent?” section above.
Your Mayzent dosage prescribed by your doctor will depend on:
- results of certain genetic tests
- whether you have problems with your liver, heart, or eyes
- any other health conditions you may have
Your doctor will recommend the dosage of Mayzent that’s right for you. Below are commonly used dosages, but always take the dosage your doctor prescribes.
Form and strengths
Mayzent is available as an oral tablet in three strengths: 0.25 milligrams (mg), 1 mg, and 2 mg.
Recommended dosages
Before you start Mayzent treatment, your doctor will order certain tests to check whether you should take the drug. (For specifics, see “Will I need to have tests or exams before starting Mayzent?” in the “What are some frequently asked questions about Mayzent?” section above.)
They will likely also check your blood to find out your genetic type of the enzyme CYP2C9. (Enzymes are certain types of proteins.) CYP2C9 helps break down medications in your body. Learning about the genetic type you have for this enzyme can help your doctor decide on the dose of Mayzent that’s right for you.
Below are commonly used dosages, but the dosage you receive will be determined by your doctor.
Dosage for MS
When you first start Mayzent to treat multiple sclerosis (MS), you’ll take a low dose of the drug once each day. Your doctor will slowly increase your daily dose over time. Because your dosage may change, your doctor will likely prescribe the starter pack (blister pack) for this beginning phase of treatment. This phase of Mayzent treatment typically lasts 4–5 days. After that, you’ll take a maintenance (ongoing) dose of Mayzent once each day.
Depending on your genetic type of the enzyme CYP2C9, your dosage may be one of the following:
- Maintenance dosage of 1 mg: You’ll take 0.25 mg for 2 days, followed by 0.50 mg for 1 day and 0.75 mg for 1 day. Then you’ll take a maintenance dosage of 1 mg once each day.
- Maintenance dosage of 2 mg: You’ll take 0.25 mg for 2 days, followed by 0.50 mg for 1 day, 0.75 mg for 1 day, and 1.25 mg for 1 day. Then you’ll take a maintenance dosage of 2 mg once each day.
How to take
Mayzent comes as oral tablets, which you’ll swallow once each day.
You should try to take Mayzent at the same time every day to avoid missed doses.
Missing doses of Mayzent can slow your progress with treatment. And in some cases of missed doses, you may have to restart the drug at the beginning phase of treatment. (For more information, see the “Recommended dosages” section just above.)
Questions about taking Mayzent
Here are some answers to common questions about taking Mayzent.
What if I miss a dose of Mayzent? Mayzent is taken in two phases: the beginning phase, which can last 4 or 5 days, and the maintenance phase, which is ongoing.
If you miss the first few doses of the beginning phase, you may need to start over again from day 1. But be sure to check with your doctor about this.
If you miss a Mayzent dose in the maintenance phase, take the missed dose as soon as you remember. But don’t double up by taking more than one dose at a time. If you’ve missed more than one Mayzent dose, call your doctor to ask about your dosing schedule. And, if you have trouble remembering to take your doses of Mayzent, try setting a reminder on your phone. Or use another reminder tool, such as an app, to help you stay on track with treatment.
Will I need to use Mayzent long term? Mayzent is meant to be taken long term for MS. Your doctor will discuss with you your treatment with Mayzent, and they’ll monitor how you’re doing with the drug. If Mayzent is safe and effective for you, your doctor may recommend that you take it long term.
Can Mayzent be chewed, crushed, or split? No, you should not crush, chew, or split Mayzent tablets. Doing so may change how the drug works in your body. If you have trouble swallowing pills, see this article for a few tips. Your doctor or pharmacist can also advise you on how to take this medication.
Should I take Mayzent with food? You can take Mayzent with or without food.
How long does Mayzent take to work? Mayzent starts working soon after you begin taking it. But it may take a few days for you to notice any changes in your MS symptoms. Your doctor can tell you more about the treatment progress you can expect with Mayzent.
Questions for your doctorYou may have questions about Mayzent and your treatment plan. It’s important to discuss all your concerns with your doctor.
Here are a few tips that might help guide your discussion:
- Before your appointment, write down questions like:
- How will Mayzent affect my body, mood, or lifestyle?
- Bring someone with you to your appointment if doing so will help you feel more comfortable.
- If you don’t understand something related to your condition or treatment, ask your doctor to explain it to you.
Remember, your doctor and other healthcare professionals are available to help you. And they want you to get the best care possible. So don’t be afraid to ask questions or offer feedback on your treatment.
Before starting Mayzent, talk with your doctor about:
- any other medications you take, including prescription and over-the-counter types
- all of your health conditions
If you take heart or blood pressure medications, your doctor may need to adjust your dosage of Mayzent. In some cases, the drug may not be safe for you to take.
These and other considerations are described below.
Interactions
Taking medications, vaccines, foods, and other things with a certain drug can affect how the drug works. These effects are called interactions.
Before taking Mayzent, be sure to tell your doctor about all medications you take (including prescription and over-the-counter types). Also, describe any vitamins, herbs, or supplements you use. Your doctor or pharmacist can tell you about any interactions these items may cause with Mayzent.
Interactions with drugs or supplements
Mayzent can interact with several types of drugs, including:
- Certain heart medications. If you take certain medications that slow your heart rate, Mayzent may not be safe for you to take. Talk with your doctor about your heart health and all of your heart medications. Your doctor will discuss with you the risks and benefits of Mayzent and other treatment options. Examples of heart medications that can interact with Mayzent include:
- beta-blockers, such as propranolol (Inderal LA)
- calcium channel blockers, such as verapamil (Verelan, Verelan PM)
- digoxin
- Drugs that inhibit certain liver enzymes. Certain liver enzymes (types of proteins) in your body help to break down Mayzent. Drugs that inhibit (block) this process can cause levels of Mayzent to build up in your system. And this can increase your risk of side effects from Mayzent. An example of an enzyme inhibitor drug is the antifungal fluconazole (Diflucan). Drugs that are moderate or strong enzyme inhibitors should not be used together with Mayzent. To avoid this interaction, tell your doctor about all of the medications you take.
- Drugs that induce certain liver enzymes. Some drugs can induce (speed up) the effects of certain liver enzymes when they’re taken together with Mayzent. And this can lead to Mayzent being cleared too quickly from your body. As a result, your body may not get the full effect of Mayzent. Examples of enzyme-inducer drugs include the antibiotic rifampin (Rifadin) and the seizure drug carbamazepine (Tegretol, Epitol). Drugs that cause moderate to strong enzyme-inducing effects shouldn’t be taken with Mayzent. To avoid this interaction, tell your doctor about all of the medications you take.
- Certain cancer medications. Certain cancer drugs weaken (suppress) your immune system’s activity when taken with Mayzent. And Mayzent also weakens your immune system’s activity. Taking these drugs together can increase your risk of infections. An example is the cancer drug alemtuzumab (Campath). It’s important to tell your doctor if you’re taking any medications that weaken the activity of your immune system. Your doctor will let you know whether Mayzent is safe for you to take.
- Certain immunosuppressant drugs. Similar to the cancer drugs described above, immunosuppressant drugs also suppress your immune system’s activity. So taking an immunosuppressant with Mayzent can increase your risk of infections. Examples of immunosuppressants include adalimumab (Humira), etanercept (Enbrel), and corticosteroids. Talk with your doctor about whether it’s safe for you to take an immunosuppressant drug with Mayzent.
This list does not contain all types of drugs that may interact with Mayzent. Your doctor or pharmacist can tell you more about these interactions and any others that may occur with the use of Mayzent.
Warnings
Mayzent may not be right for you if you have certain medical conditions or other factors that affect your health. Talk with your doctor about your health history before you take Mayzent. Factors to consider include those in the list below.
- Heart problems. Mayzent can slow your heart rate and delay the electrical activity in your heart. If you already have certain heart conditions, such as slow heart rate or heart block, treatment with Mayzent could worsen your condition. Your doctor will order an electrocardiogram (EKG) to check your heart health before you start taking Mayzent. If you’ve had a heart attack, stroke, or heart failure, or have been diagnosed with other serious heart conditions in the past 6 months, Mayzent may be contraindicated (not recommended) for you. If you have any heart-related problems, you may need to see a heart specialist before starting treatment with Mayzent to make sure the drug is safe for you.
- Diabetes or uveitis. If you have diabetes or uveitis, you have an increased risk of developing macular edema with Mayzent. If you have either of these conditions, your doctor may recommend more frequent eye checkups during Mayzent treatment.
- Certain genetic traits. Before starting Mayzent, your doctor may test you to find out your genetic type of the enzyme CYP2C9. Mayzent is contraindicated in people with a certain type of this gene. Talk with your doctor if you’d like to know more about this genetic test.
- Allergic reaction. If you’ve had an allergic reaction to Mayzent or any of its ingredients, you shouldn’t take Mayzent. Ask your doctor what other medications are better options for you.
- Lung problems. If you have any lung conditions that affect your breathing, such as asthma, Mayzent may worsen your breathing problem. Tell your doctor about any lung problems you have and ask them if Mayzent is safe for you.
Use with alcohol
There aren’t any known interactions between Mayzent and alcohol. However, Mayzent can cause dizziness and certain liver problems, such as increased liver enzymes. Alcohol can also cause these effects. So drinking alcohol with Mayzent may worsen the effects.
If you drink alcohol, ask your doctor whether it’s safe to drink while you’re taking Mayzent.
Pregnancy and breastfeeding
It’s not known whether Mayzent is safe for use during pregnancy, but it’s thought that it may cause fetal harm.
If you’re a female* taking Mayzent, it’s recommended that you use effective birth control during treatment. And you should continue using birth control for at least 10 days after your last dose of Mayzent.
If you’re pregnant or planning to become pregnant, ask your doctor about the risks of using Mayzent. They can also tell you about other treatment options for your condition.
If you and your doctor decide that you’ll use Mayzent during pregnancy, consider joining the pregnancy registry for this drug. Pregnancy registries help gather information about the use of medications during pregnancy. You can learn more and sign up for the registry by calling 877-311-8972 or by visiting this site.
It is not known whether Mayzent is safe for use while breastfeeding. So be sure to talk with your doctor about the risks of using Mayzent if you’re breastfeeding or planning to breastfeed. Your doctor may discuss other options for feeding your child while you’re taking Mayzent.
* In this article, we use the term “female” to refer to someone’s sex assigned at birth. For information about the difference between sex and gender, see this article.
Do not take more Mayzent than your doctor prescribes. Using more than the prescribed amount can lead to serious side effects. For example, taking too much Mayzent may increase heart-related side effects.
If an overdose occurs, you may need close monitoring to avoid serious heart problems, which may be life threatening. Specifically, your blood pressure and heart rate would be monitored.
Symptoms of overdose
Symptoms caused by Mayzent overdose can include slow heart rate.
What to do in case you take too much Mayzent
Call your doctor if you think you’ve taken too much Mayzent.
You can also call 800-222-1222 to reach America’s Poison Centers or use its online resource. However, if you have severe symptoms, immediately call 911 (or your local emergency number) or go to the nearest emergency room.
Mayzent is one treatment option to consider if you have certain types of multiple sclerosis (MS) or clinically isolated syndrome (CIS). To learn about these conditions, see the “Is Mayzent used for MS?” section above.
Before starting treatment with Mayzent, talk with your doctor about all the benefits and risks of using this drug for certain types of MS or CIS. Some questions to consider asking your doctor include:
- Will I need to have blood work done while I’m taking Mayzent?
- If I have heart problems, is Mayzent safe for me to take?
- What other treatment options are available for my condition?
- Will Mayzent cure my MS?
To learn more about all the treatment options for MS, check out these articles:
- MS Treatment Chart: Comparing Disease-Modifying Therapies
- Multiple Sclerosis (MS) drugs
- Promising Changes in the Landscape of MS Treatments
To get information on different conditions and tips for improving your health, subscribe to any of Healthline’s newsletters. You may also want to check out the online communities at Bezzy. It’s a place where people with certain conditions can find support and connect with others.
Q:
While I’m taking Mayzent, is it safe for me to get a flu vaccine or other vaccinations, such as a COVID-19 vaccine?
AnonymousA:
Certain vaccines should be avoided while you’re taking Mayzent.
Specifically, you shouldn’t get any live attenuated vaccines. These vaccines are made with weakened forms of a live virus. You should not receive them during Mayzent treatment and for at least 4 weeks after your last dose of Mayzent.
Examples of live vaccines include:
- measles, mumps, rubella (MMR)
- varicella-zoster (chickenpox)
- rotavirus
- nasal flu vaccine (flu vaccine given by nose)
The COVID-19 vaccines that are currently available aren’t live vaccines. But talk with your doctor about whether you should receive one while you’re using Mayzent.
If you have more questions about which vaccines you can receive while using Mayzent, talk with your doctor.
The Healthline Pharmacist TeamAnswers represent the opinions of our medical experts. All content is strictly informational and should not be considered medical advice.Disclaimer: Healthline 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 other 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.