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
- 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
- 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
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
- Arm or leg pain
- diarrhea
- falls
Less common
- Lack or loss of strength
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]
