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Ponesimod Side Effects

Medically reviewed by Drugs.com. Last updated on Oct 1, 2022.

Applies to ponesimod: oral tablet.

Serious side effects of Ponesimod

Along with its needed effects, ponesimod 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 ponesimod:

More common

  • Agitation
  • back pain
  • bladder pain
  • body aches or pain
  • burning or stinging of the skin
  • chest pain, discomfort, or tightness
  • chills
  • coma
  • confusion
  • cough
  • cough producing mucus
  • dark urine
  • difficult, burning, or painful urination
  • dizziness
  • drowsiness
  • ear congestion
  • fever
  • general feeling of illness
  • hallucinations
  • headache
  • hoarseness
  • irritability
  • lightheadedness, dizziness, or fainting
  • loss of appetite
  • loss of voice
  • lower back or side pain
  • mood or mental changes
  • nausea
  • nervousness
  • nosebleeds
  • numbness or tingling in the face, arms, or legs
  • painful cold sores or blisters on the lips, nose, or genitals
  • pounding in the ears
  • runny or stuffy nose
  • seizures
  • skin rash on the face, scalp, or stomach
  • slow or irregular heartbeat
  • stiff neck or back
  • sneezing
  • sore throat
  • stomach pain
  • tender, swollen glands in the neck
  • trouble breathing
  • trouble in swallowing
  • unusual tiredness or weakness
  • vision problems
  • voice changes
  • vomiting
  • yellow eyes or skin

Less common

  • Bloating or swelling of the face, arms, hands, lower legs, or feet
  • blurred vision or other change in vision
  • discouragement
  • feeling of constant movement of self or surroundings
  • feeling sad or empty
  • headache, severe and throbbing
  • loss of interest or pleasure
  • painful blisters on the trunk of the body
  • rapid weight gain
  • sensation of spinning
  • tingling of the hands or feet
  • trouble concentrating
  • trouble sleeping
  • unusual weight gain or loss

Rare

  • Change in size, shape, or color of the existing mole
  • new mole
  • mole that leaks fluid or bleeds
  • persistent non-healing sore
  • pink growth
  • reddish patch or irritated area
  • shiny bump
  • white, yellow, or waxy scar-like area

Other side effects of Ponesimod

Some side effects of ponesimod 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:

Less common

  • Acid or sour stomach
  • belching
  • dry mouth
  • heartburn
  • indigestion
  • pain in the arms or legs
  • pain or tenderness around the eyes and cheekbones
  • sleepiness or unusual drowsiness
  • sleeplessness
  • stomach discomfort or upset
  • trouble sleeping

For Healthcare Professionals

Applies to ponesimod: oral tablet.

Cardiovascular

Very common (10% or more): Hypertension (10%)

Common (1% to 10%): Bradycardia[Ref]

Respiratory

Very common (10% or more): Upper respiratory infection (37%)

Common (1% to 10%): Cough, dyspnea, rhinitis, sinusitis

Frequency not reported: Pneumonia[Ref]

Hematologic

Common (1% to 10%): Increased C-reactive protein, lymphopenia[Ref]

Musculoskeletal

Common (1% to 10%): Pain in extremity, joint swelling, back pain[Ref]

Ocular

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

Metabolic

Common (1% to 10%): Hypercholesterolemia, hyperkalemia[Ref]

Genitourinary

Common (1% to 10%): Urinary tract infection[Ref]

Hepatic

Very common (10% or more): Increased hepatic transaminase (23%, includes ALT, AST)[Ref]

Other

Common (1% to 10%): Vertigo, viral infection, herpes zoster[Ref]

General

Common (1% to 10%): Pyrexia, fatigue, chest discomfort, peripheral edema[Ref]

Nervous system

Common (1% to 10%): Dizziness, somnolence, migraine[Ref]

Psychiatric

Common (1% to 10%): Insomnia, depression

Gastrointestinal

Common (1% to 10%): Dyspepsia, dry mouth

References

1. "Product Information. Ponvory (ponesimod)." Janssen Pharmaceuticals (2021):

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.