Siponimod Side Effects
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 side effects
- bloating or swelling of the face, arms, hands, lower legs, or feet
- blurred vision
- chest pain or discomfort
- fast, slow, or irregular heartbeat
- headache
- lightheadedness, dizziness, or fainting
- nervousness
- pounding in the ears
- rapid weight gain
- tingling of the hands or feet
- unusual tiredness or weakness
- unusual weight gain or loss
Less common side effects
- anxiety
- change in the size, shape, or color of existing mole
- change in vision
- chills
- confusion
- cough
- difficulty in speaking
- double vision
- fever
- hoarseness
- inability to move the arms, legs, or facial muscles
- inability to speak
- lower back or side pain
- mole that leaks fluid or bleeds
- nausea
- new mole
- numbness or tingling in the face, arms or legs
- pain or discomfort in the arms, jaw, back, or neck
- painful blisters on the trunk of the body
- painful or difficult urination
- persistent non-healing sore
- pink growth
- pounding, slow heartbeat
- reddish patch or irritated area
- seizures
- shiny bump
- slow speech
- sweating
- tremor
- trouble speaking, thinking, or walking
- trouble breathing
- vomiting
- white, yellow, or waxy scar-like area
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:
More common side effects
- arm or leg pain
- diarrhea
- falls
Less common side effects
- lack or loss of strength
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
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]
References
1. (2019) "Product Information. Mayzent (siponimod)." Novartis Pharmaceuticals
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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.
Some side effects may not be reported. You may report them to the FDA.