Siponimod Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jul 1, 2024.

Applies to siponimod: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects. Your doctor will also check your skin for any changes before and during treatment with this medicine.

Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 10 days after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may increase your risk of developing infections, including a herpes infection or a serious brain infection called meningitis or progressive multifocal leukoencephalopathy. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Siponimod may cause a rare condition called immune reconstitution inflammatory syndrome (IRIS). This may occur after a person stops receiving this medicine after developing PML during treatment. Tell your doctor right away if you have an inflammatory reaction to an infection that includes mild burning, stinging, or tingling of the skin, or a feeling of heat, redness, or swelling of the skin.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

This medicine may cause heart rhythm problems. Tell your doctor right away if you get dizzy or lightheaded, have a fast, slow, or irregular heartbeat, or feel like fainting.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Your doctor will check your blood pressure on a regular basis while you are using this medicine. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision.

This medicine may increase your risk of having skin cancer (eg, basal cell carcinoma, melanoma, squamous cell carcinoma). Tell your doctor right away if you notice any skin nodules, patches, or open sores that do not quickly heal. Avoid exposure to sunlight. Wear sunscreen with a high sun protection factor. Do not use sunlamps or tanning beds.

Tell your doctor right away if you have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).

While you are being treated with siponimod, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. You should not receive a live vaccine during treatment with this medicine and for 4 weeks after the last dose. Do not use this medicine 1 week before and for 4 weeks after receiving a live vaccine. Siponimod may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

Serious side effects of siponimod

Along with its needed effects, siponimod may cause some unwanted effects. Although not all of these side effects may occur, if they do occur they may need medical attention.

Check with your doctor immediately if any of the following side effects occur while taking siponimod:

incidence not known

• back pain
• drowsiness
• fever

Other side effects of siponimod

Some side effects of siponimod may occur that usually do not need medical attention. These side effects may go away during treatment as your body adjusts to the medicine. Also, your health care professional may be able to tell you about ways to prevent or reduce some of these side effects.

Check with your health care professional if any of the following side effects continue or are bothersome or if you have any questions about them:

For healthcare professionals

Applies to siponimod: oral tablet.

Hematologic adverse events

• Common (1% to 10%): Lymphopenia^[Ref]

Immunologic

• Very common (10% or more): Infections (e.g., herpes zoster, bronchitis, sinusitis, upper respiratory infection, fungal skin infection) (49%)^[Ref]

Musculoskeletal

• Common (1% to 10%): Pain in extremity^[Ref]

Ocular

• Common (1% to 10%): Macular edema^[Ref]

Metabolic

• Common (1% to 10%): Edema peripheral (e.g., edema peripheral, joint swelling, fluid retention, swelling face)^[Ref]

Hepatic

• Very common (10% or more): Elevations in transaminases (e.g., alanine aminotransferase increased, gamma-glutamyltransferase increased, hepatic enzyme increased, aspartate aminotransferase increased, blood alkaline phosphatase increased, liver function test increased, hepatic function abnormal, liver function test abnormal, transaminases increased) (10%), increased bilirubin (10%)^[Ref]

Oncologic

• Frequency not reported: Malignancy (e.g., melanoma in situ, seminoma)^[Ref]

Respiratory

• Very common (10% or more): Bronchitis, sinusitis, upper respiratory infection
• Common (1% to 10%): Pulmonary embolism, pulmonary function test decreased^[Ref]

Other

• Very common (10% or more): Falls (11%)
• Common (1% to 10%): Macular edema, asthenia^[Ref]

Nervous system

• Very common (10% or more): Headache (e.g., headache, tension headache, sinus headache, cervicogenic headache, drug withdrawal headache, procedural headache) (15%)
• Common (1% to 10%): Dizziness, seizure, tremor
• Frequency not reported: Posterior reversible encephalopathy syndrome (PRES)^[Ref]

Cardiovascular

• Very common (10% or more): Hypertension (e.g., blood pressure increased, blood pressure systolic increased, essential hypertension, blood pressure diastolic increased) (13%)
• Common (1% to 10%): First-degree AV block, second-degree AV block (usually Mobitz type I), bradycardia, ischemic stroke, myocardial infarction^[Ref]

Dermatologic

• Very common (10% or more): Fungal skin infection^[Ref]

Gastrointestinal

• Common (1% to 10%): Nausea, diarrhea^[Ref]

See also:

Frequently asked questions

• What are the new drugs used for multiple sclerosis (MS)?

Further information

Siponimod side effects can vary depending on the individual. Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer