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Siponimod Side Effects

Medically reviewed by Philip Thornton, DipPharm. Last updated on Jan 18, 2024.

Applies to siponimod: oral tablet.

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:

More common

Less common

incidence not known

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:

More common

Less common

For Healthcare Professionals

Applies to siponimod: oral tablet.

Hematologic

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]

Frequently asked questions

References

1. Product Information. Mayzent (siponimod). Novartis Pharmaceuticals. 2019.

Further information

Always consult your healthcare provider to ensure the information displayed on this page applies to your personal circumstances.

Some side effects may not be reported. You may report them to the FDA.