Ponesimod Side Effects

Medically reviewed by Drugs.com. Last updated on Dec 19, 2024.

Applies to ponesimod: oral tablet.

Precautions

It is very important that your doctor check your progress at regular visits to make sure this medicine is working properly. Blood and urine tests may be needed to check for any unwanted effects.

Symptoms of your MS may return and become worse after stopping treatment with this medicine. Do not stop using this medicine without checking first with your doctor.

Using this medicine while you are pregnant can harm your unborn baby. Use an effective form of birth control to keep from getting pregnant during treatment with this medicine and for 1 week after the last dose. If you think you have become pregnant while using this medicine, tell your doctor right away.

This medicine may increase your risk of developing infections, including a herpes infection or a serious brain infection called meningitis or progressive multifocal leukoencephalopathy. Avoid being near people who are sick or have infections while you are using this medicine. Wash your hands often. Also tell your doctor if you have ever had an infection that would not go away or an infection that kept coming back.

Ponesimod may cause a rare condition called immune reconstitution inflammatory syndrome (IRIS). This may occur after a person stops receiving this medicine after developing PML during treatment. Tell your doctor right away if you have an inflammatory reaction to an infection that includes mild burning, stinging, or tingling of the skin, or a feeling of heat, redness, or swelling of the skin.

This medicine may cause heart rhythm problems. Tell your doctor right away if you get dizzy or lightheaded, have a fast, slow, or irregular heartbeat, or feel like fainting.

Tell your doctor right away if you have a cough, trouble breathing, chest tightness, or any type of breathing problem with this medicine. These could be symptoms of a serious lung problem.

Check with your doctor right away if you have pain or tenderness in the upper stomach, pale stools, dark urine, loss of appetite, nausea, vomiting, or yellow eyes or skin. These could be symptoms of a serious liver problem.

Your doctor will check your blood pressure on a regular basis while you are using this medicine. Tell your doctor right away if you have a severe headache, lightheadedness, or changes in your vision.

This medicine may increase your risk of having skin cancer (eg, basal cell carcinoma, melanoma, squamous cell carcinoma). Tell your doctor right away if you notice any skin nodules, patches, or open sores that do not quickly heal. Avoid exposure to sunlight. Wear sunscreen with a high sun protection factor. Do not use sunlamps or tanning beds.

Check with your doctor right away if blurred vision, difficulty with reading, or any other change in vision occurs during or after treatment. Your doctor may want your eyes be checked by an ophthalmologist (eye doctor).

Tell your doctor right away if you have seizures, headache, confusion, vision problems, unusual drowsiness, tiredness, or weakness. These could be symptoms of a serious nervous system problem called posterior reversible encephalopathy syndrome (PRES).

While you are being treated with ponesimod, and after you stop treatment with it, do not have any immunizations (vaccinations) without your doctor's approval. Do not use this medicine 1 to 2 weeks before and for 4 weeks after receiving a vaccine. Ponesimod may lower your body's resistance and there is a chance you might get the infection the immunization is meant to prevent. In addition, other persons living in your household should not take oral polio vaccine since there is a chance they could pass the polio virus on to you. Also, avoid persons who have taken oral polio vaccine within the last several months. Do not get close to them, and do not stay in the same room with them for very long. If you cannot take these precautions, you should consider wearing a protective face mask that covers the nose and mouth.

Do not take other medicines unless they have been discussed with your doctor. This includes prescription or nonprescription (over-the-counter [OTC]) medicines and herbal or vitamin supplements.

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:

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:

For healthcare professionals

Applies to ponesimod: oral tablet.

General adverse events

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

• Uncommon (0.1% to 1%): Basal cell carcinoma, melanoma
• Frequency not reported: Squamous cell carcinoma

Dermatologic

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

• Very common (10% or more): Upper respiratory infection (37%)
• Common (1% to 10%): Cough, dyspnea, rhinitis, sinusitis
• Frequency not reported: Pneumonia^[Ref]

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]

See also:

Further information

Ponesimod 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.

Note: Medication side effects may be underreported. If you are experiencing side effects that are not listed, submit a report to the FDA by following this guide.

Medical Disclaimer