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.
General
-The most common adverse reactions occurring in more than 10% of patients taking this drug included upper respiratory infection (37%), increased hepatic transaminase (23%) and hypertension (up to 10%).[Ref]
Cardiovascular
Very common (10% or more): Hypertension (up to 10%)
Common (1% to 10%): Bradycardia[Ref]
Dermatologic
Dermatologic
Uncommon (0.1% to 1%): Basal cell carcinoma, melanoma
Frequency not reported: Squamous cell carcinoma
Gastrointestinal
Common (1% to 10%): Dyspepsia, dry mouth
Genitourinary
Common (1% to 10%): Urinary tract infection[Ref]
Hematologic
Common (1% to 10%): Increased C-reactive protein, lymphopenia[Ref]
Hepatic
Very common (10% or more): Increased hepatic transaminase (23%, includes ALT, AST)[Ref]
Most patients with ALT increases of 3 times or greater than the upper limit of normal resolved on continued treatment with this drug within approximately 2-4 weeks.[Ref]
Metabolic
Common (1% to 10%): Hypercholesterolemia, hyperkalemia[Ref]
Musculoskeletal
Common (1% to 10%): Pain in extremity, joint swelling, back pain, ligament sprain, arthralgia[Ref]
Nervous system
Common (1% to 10%): Dizziness, somnolence, migraine, seizures, hypoesthesia[Ref]
Ocular
Common (1% to 10%): Macular edema[Ref]
Other
Common (1% to 10%): Chest discomfort, fatigue, peripheral edema, pyrexia, vertigo, viral infection, herpes zoster[Ref]
Psychiatric
Common (1% to 10%): Insomnia, depression, anxiety
Respiratory
Upper respiratory infections included: nasopharyngitis, upper respiratory tract infection, pharyngitis, respiratory tract infection, bronchitis, respiratory tract infection viral, viral upper respiratory tract infection, tracheitis, and laryngitis.[Ref]
Very common (10% or more): Upper respiratory infection (37%)
Common (1% to 10%): Cough, dyspnea, rhinitis, sinusitis
Frequency not reported: Pneumonia[Ref]
