Zeposia (ozanimod) is a brand-name prescription medication. It’s approved by the Food and Drug Administration (FDA) to treat the following conditions in adults:
- certain forms of multiple sclerosis (MS), including:
- moderate to severe ulcerative colitis
Here are some fast facts about Zeposia:
- Active ingredient: ozanimod
- Drug class: sphingosine-1-phosphate receptor modulator, a type of immunomodulator
- Drug form: oral capsule
- FDA approval year: 2020
Zeposia is typically prescribed as a long-term treatment.
Similar to other drugs, Zeposia can cause side effects. Read on to learn about potential common, mild, and serious side effects. For a general overview of Zeposia, including details about its uses, see this article.
Zeposia can cause certain side effects, some of which are more common than others. These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
These are just a few of the more common side effects reported by people who took Zeposia in clinical trials. These side effects can vary depending on which condition the drug is prescribed to treat.
More common side effects in people taking Zeposia for multiple sclerosis include:
- infection, such as upper respiratory infection and urinary tract infection (UTI)
- orthostatic hypotension (sudden drop in blood pressure when you change positions)*
- back pain
- high blood pressure*
- increased liver enzymes*
More common side effects in people taking Zeposia for ulcerative colitis include:
- upper respiratory infection
- headache
- increased liver enzymes*
* For more information about this side effect, see “Side effect specifics” below.
Mild side effects can occur with Zeposia. This list doesn’t include all possible mild side effects of the drug. For more information, you can refer to Zeposia’s prescribing information.
Zeposia’s mild side effects can vary depending on which condition the drug is prescribed to treat.
Mild side effects that have been reported with Zeposia treatment for multiple sclerosis include:
- mild infection, such as upper respiratory infection and urinary tract infection (UTI)
- back pain
- pain in your upper abdomen
- swelling due to fluid buildup in your hands, legs, or feet
- increased liver enzymes*
Mild side effects that have been reported with Zeposia treatment for ulcerative colitis include:
- upper respiratory infection
- headache
- fever
- nausea
- joint pain
- swelling due to fluid buildup in your hands, legs, or feet
- increased liver enzymes*
* For more information about this side effect, see “Side effect specifics” below.
These side effects may be temporary, lasting a few days to weeks. However, if the side effects last longer than that, bother you, or become severe, be sure to talk with your doctor or pharmacist.
Note: After the Food and Drug Administration (FDA) approves a drug, it tracks side effects of the medication. If you develop a side effect while taking Zeposia and want to tell the FDA about it, visit MedWatch.
Zeposia may cause serious side effects. Serious side effects are possible regardless of which condition the drug is prescribed to treat.
The list below may not include all possible serious side effects of the drug. For more information, you can refer to Zeposia’s prescribing information.
If you develop serious side effects during Zeposia treatment, call your doctor right away. If the side effects seem life threatening or you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Serious side effects that have been reported and their symptoms include:
- Changes in your lung function. Signs and symptoms can include:
- reduced forced expiratory volume (the amount of air you can forcefully exhale, as measured by a pulmonary function test)
- Serious infection, such as shingles or progressive multifocal leukoencephalopathy (a viral brain infection). Symptoms can vary. However, they may include:
- pain, a burning sensation, or weakness on one side of your body
- fever
- clumsiness of your arms or legs
- vision changes
- Increased risk of cancer. Symptoms can vary. However, they may include:
- unexplained weight loss or weight gain
- constant fatigue
- fever
- unusual pain, lumps, or swelling in your body
- Posterior reversible encephalopathy syndrome (a condition caused by narrowing and swelling of blood vessels in your brain). Symptoms can start suddenly and may include:
- severe headache
- vision problems or vision loss
- confusion
- Orthostatic hypotension (sudden drop in blood pressure when you change positions).*
- High blood pressure.*
- Macular edema (fluid buildup in the macula, an area in the center of your eye).*
- Slow heart rate.*
- Allergic reaction.*
* For more information about this side effect, see “Side effect specifics” below.
Zeposia may cause several side effects. Here are some frequently asked questions about the drug’s side effects and their answers.
Does Zeposia cause ocular (eye) side effects?
It’s possible. In clinical trials, some people who took Zeposia for multiple sclerosis or ulcerative colitis had an eye problem called macular edema. (With macular edema, fluid builds up in the macula, an area in the center of your eye. To learn more, see the “Side effects specifics” section below.)
You may have an increased risk of developing macular edema while taking Zeposia if you have certain conditions. These include diabetes or uveitis (swelling of the uvea, the middle layer of the eye). You may also have an increased risk of macular edema if you had these conditions in the past.
In rare cases, sudden vision changes can be a sign of other serious side effects, such as posterior reversible encephalopathy syndrome (PRES). (PRES is a condition caused by the narrowing and swelling of blood vessels in your brain.)
If you have any vision changes while you’re taking Zeposia, tell your doctor right away.
I’m taking Zeposia for ulcerative colitis (UC). What side effects can I expect?
In clinical trials, the following side effects were more common in people who took Zeposia for UC:
- increased liver enzymes, which can sometimes be an early sign of liver damage
- upper respiratory infection, such as sinusitis (inflammation of the sinuses)
- headache
Zeposia’s more common side effects are typically mild or manageable. However, other more severe side effects are possible. (For more information, see the “Mild side effects of Zeposia” and “Serious side effects of Zeposia” sections above.)
If you have questions about side effects of Zeposia while taking it for UC, talk with your doctor or pharmacist.
Learn more about some of the side effects that Zeposia may cause. To find out how often side effects occurred in clinical trials, see the prescribing information for Zeposia.
Increased liver enzymes
Zeposia may cause increased levels of liver enzymes in the blood. Increased liver enzymes can sometimes be an early sign of liver damage.
In clinical trials of people with multiple sclerosis (MS) or ulcerative colitis (UC), this side effect was typically mild and temporary. Rarely, some people developed severely increased liver enzymes. These people had to stop taking the drug.
You should watch for symptoms that could be signs of liver damage during Zeposia treatment. These include:
What you can do
Your doctor may have you get a liver function test before you start Zeposia treatment. Liver function tests are a type of blood test that measures the liver enzyme levels in your blood. Your doctor may have you repeat this blood test while you’re taking Zeposia.
Tell your doctor right away if you have any of the symptoms listed above. If they confirm you have liver damage, they’ll have you stop Zeposia treatment. After your last dose, your liver enzyme levels should decrease. And they should return closer to typical levels in about 2 to 4 weeks.
Orthostatic hypotension
Some people may have orthostatic hypotension as a side effect of Zeposia treatment. Orthostatic hypotension is a sudden drop in blood pressure that occurs when you change positions. This includes when you stand up quickly from sitting or lying down. It’s also called postural hypotension.
In clinical trials, this side effect was common in people taking Zeposia for MS. It wasn’t reported in people taking Zeposia for UC.
Symptoms of orthostatic hypotension may include:
- dizziness
- blurry vision
- fainting or feeling as though you’re going to faint
Falling and fall-related injuries are also common complications of orthostatic hypotension.
Orthostatic hypotension is typically mild and temporary in most people. However, if you have a heart condition or other factors that cause low blood pressure, this side effect may affect you more severely. In fact, Zeposia isn’t recommended for people with certain medical conditions. (For more information, see the “Precautions for Zeposia” section below.)
It’s important to note that orthostatic hypotension can also be a symptom of MS. To learn more about how MS causes orthostatic hypotension, talk with your doctor.
What you can do
One of the best ways to manage orthostatic hypotension is to avoid sudden movements. Be sure to take your time when you get up from a seated or lying position. Try to get out of bed slowly, taking an extra minute to sit up in bed before standing. Keeping yourself hydrated with plenty of fluids is another way to manage this side effect.
If this side effect is bothersome or severe, talk with your doctor. They may suggest other ways to manage this side effect. Or they may suggest a different treatment option for you.
High blood pressure
Hypertension (high blood pressure) can occur during Zeposia treatment. This side effect was seen in some people taking the drug for MS or UC. In these trials, high blood pressure was more common in people taking Zeposia with Rebif (interferon beta-1a). (Rebif is another medication that’s prescribed to treat MS.)
High blood pressure doesn’t typically cause any symptoms.
Rarely, hypertensive crisis (a sudden, severe increase in blood pressure) has occurred in people taking Zeposia for MS or UC. Symptoms of very high blood pressure may include:
- headache
- chest pain
- trouble breathing
- dizziness
- confusion
- nausea and vomiting
What you can do
Your doctor will monitor your blood pressure during Zeposia treatment. They may also have you check your blood pressure at home.
Other ways to manage your blood pressure include regular exercise and limiting certain foods. These include foods high in sodium (salt) and tyramine-rich foods such as aged, fermented, or smoked food products. (Tyramine is a byproduct of an amino acid found in certain foods.)
If your blood pressure becomes high, your doctor may prescribe a blood pressure medication. Or they may recommend a medication other than Zeposia to treat your condition.
Macular edema
Zeposia may cause an eye problem called macular edema. This side effect was rare in people taking Zeposia for MS or UC in clinical trials.
Macular edema occurs when fluid builds up in the macula, an area in the center of your retina. (The retina is a thin layer of tissue on the back of your eye.)
With macular edema, fluid builds up in the macula and causes it to swell. This leads to vision changes, including:
- blurry, wavy, or distorted vision
- seeing colors that are more faded than is typical
You may have an increased risk of developing macular edema during Zeposia treatment if you have certain conditions. These include diabetes or uveitis (swelling of the uvea, the middle layer of the eye). You may also have an increased risk of this side effect if you had these conditions in the past.
What you can do
Depending on your past and current medical conditions, your doctor may have you get an eye exam before they prescribe you Zeposia. Be sure to keep up with your regular eye exams while you’re taking Zeposia.
If you notice any changes in your vision, tell your doctor right away. If they determine you have macular edema, you may need treatment with surgery. Or they may recommend medication, such as Lucentis (ranibizumab), to treat this side effect. You and your doctor will weigh the risks and benefits of continuing Zeposia treatment.
Slow heart rate
Rarely, Zeposia treatment may cause temporary bradycardia (slow heart rate). A related side effect called heart block may also occur with Zeposia. (Heart block involves a slow-down or delay in the heart’s regular rhythm.)
These side effects were rare in clinical trials for MS and UC. However, when they occurred, they were more common in the first week of treatment.
Symptoms of slow heart rate or slow heart rhythm can include:
If you already have certain heart conditions, this side effect may affect you more severely. In fact, Zeposia isn’t recommended for people with certain medical conditions. (For more information, see the “Precautions for Zeposia” section below.)
What you can do
Before prescribing Zeposia, your doctor will check your heart function using an electrocardiogram (ECG) test. Depending on the results, a cardiologist (heart specialist) may need to determine if it’s safe for you to take Zeposia.
When you start Zeposia, be sure to take it exactly as your doctor recommends. You’ll typically start treatment with a low dose. Then your dose will be slowly increased over the first week of treatment. Be sure to follow the dosing schedule your doctor recommends for you. This can help lower your risk of slow heart rate and related heart problems. (To learn more about Zeposia dosage, see this article.)
Allergic reaction
As with most drugs, Zeposia can cause an allergic reaction in some people. Allergic reactions were reported in clinical trials of Zeposia for MS. However, it’s not clear how often these reactions occurred. Allergic reactions were not reported in clinical trials for UC.
Symptoms can be mild or serious and can include:
- skin rash or hives
- itching
- flushing
- swelling under your skin, typically in your eyelids, lips, hands, or feet
- swelling of your mouth, tongue, or throat, which can make it hard to breathe
What you can do
For mild symptoms of an allergic reaction, call your doctor right away. They may recommend ways to ease your symptoms and determine whether you should keep taking Zeposia. However, if your symptoms are serious and you think you’re having a medical emergency, immediately call 911 or your local emergency number.
Be sure to talk with your doctor about your health history before you take Zeposia. This drug may not be the right treatment option for you if you have certain medical conditions or other factors that affect your health.
Due to a serious risk of harm, doctors will typically not prescribe Zeposia to people with the following conditions or factors:
- Certain heart problems within the past 6 months, such as:
- transient ischemic attack (ministroke)
- unstable angina (a type of chest pain)
- certain types of heart failure
- Heart rhythm problems that aren’t managed with a pacemaker.
- Breathing problems, such as sleep apnea (a disorder that repeatedly pauses your breathing while you sleep).
Also, Zeposia isn’t prescribed to people who are currently taking drugs known as monoamine oxidase inhibitors (MAOIs). (These are drugs that are typically prescribed to treat depression.) Zeposia also isn’t prescribed to people who received certain vaccines within the last month.
Other conditions
Other conditions and factors that your doctor will consider when prescribing you Zeposia include:
Allergic reaction. If you’ve had an allergic reaction* to Zeposia or any of its ingredients, your doctor will likely not prescribe the drug. Talk with your doctor about what other medications may be better options for you.
Infection. Zeposia may reduce your body’s ability to fight infection. If you think you have any infections, even minor infections, talk with your doctor. They’ll likely have you wait to start Zeposia treatment until after your infection has been treated or is gone.
Low or high blood pressure. Zeposia may cause changes in your blood pressure.* If you already have blood pressure problems, taking this medication could worsen your condition. Your doctor may monitor you more closely during Zeposia treatment. They may also adjust your dosage or medications that you take to manage your blood pressure. (To learn more about Zeposia dosage, see this article.)
Diabetes. If you have diabetes and take Zeposia, you may have an increased risk of developing macular edema.* Before prescribing Zeposia, your doctor will have you get an eye exam. They’ll also monitor you for vision changes while you’re taking the drug.
An eye problem called uveitis. If you have uveitis (swelling in the middle layer of your eye) and take Zeposia, you may have an increased risk of developing macular edema.* Before prescribing the drug, your doctor will have you get an eye exam. They’ll also monitor you for vision changes during Zeposia treatment.
Liver problems. Zeposia may cause increased liver enzymes as a side effect.* This can sometimes be an early sign of liver damage. If you already have liver problems, taking Zeposia may worsen your condition. If your doctor prescribes this drug, they’ll talk with you about a plan to closely monitor your liver function.
* To learn more about this side effect, see the “Side effect specifics” section above.
Alcohol with Zeposia
Drinking most types of alcohol shouldn’t cause an interaction with Zeposia.
However, you should avoid certain fermented alcoholic drinks, such as wine and beer, while taking the drug. This is because they contain tyramine. (Tyramine is a byproduct of an amino acid found in certain foods.) And tyramine may increase the risk of high blood pressure with Zeposia.
Also, drinking alcohol frequently or more than your doctor recommends may cause liver problems. And Zeposia may not be safe in people with liver problems.
If you drink alcohol, ask your doctor how much or if any is safe for you to drink while taking Zeposia. Also, be sure to ask them what types of alcohol are safe for you to drink.
* To learn more about this side effect, see the “Side effect specifics” section above.
Pregnancy and breastfeeding while taking Zeposia
Below is information about pregnancy and breastfeeding during Zeposia treatment.
Pregnancy and Zeposia treatment
Zeposia is likely not safe to take during pregnancy. The drug hasn’t been studied in human pregnancy. However, animal studies have shown harmful effects during pregnancy. Congenital anomalies (commonly known as birth defects) and pregnancy loss occurred when pregnant animals were given the drug.
If you’re pregnant or planning a pregnancy, talk with your doctor before taking Zeposia. They can advise on your treatment options during this time.
If you’re sexually active, talk with your doctor about your birth control needs. If you’re female,* your doctor will recommend using birth control during Zeposia treatment. And they’ll recommend it for 3 months after your last dose. The drug’s manufacturer hasn’t provided information on whether males* should use birth control while taking Zeposia. If you’re male, talk with your doctor about using birth control during Zeposia treatment.
Breastfeeding and Zeposia treatment
It’s unknown if Zeposia is safe to take while breastfeeding. The drug’s effects haven’t been studied in children who are breastfed. Animal studies have shown the drug passes into animal milk. However, the drug’s effects haven’t been studied in animal offspring.
If you have questions about breastfeeding while taking Zeposia, talk with your doctor. They can advise on the risks and benefits of taking the drug.
* Sex and gender exist on spectrums. Use of the term “female” and “male” in this article refers to sex assigned at birth.
Zeposia’s common side effects are typically mild. However, serious side effects have occurred in some people. Your doctor can help you consider this medication’s benefits and risks. And they’ll help you decide if it’s the right option for you.
If you’d like to learn more about Zeposia, talk with your doctor or pharmacist. They can help answer any questions you have about side effects of taking the drug.
Besides talking with your doctor, you can do some more reading on your own. These articles might help:
- More information about Zeposia. For details about other aspects of Zeposia, refer to this article.
- Drug comparison. Learn how Zeposia compares with Gilenya and Tecfidera.
- Dosage. For more information about the drug’s dosage, see this article.
- A look at your condition:
- If you have multiple sclerosis (MS), see our MS hub and this list of related articles for details about this condition.
- For details about ulcerative colitis (UC), our IBD hub may be helpful, as well as this list of UC articles.
Disclaimer: Medical News Today 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.