Skip to main content
PlainMeds

What the label lists and what reports show

Ponesimod side effects

Ponesimod's FDA label: “Most common adverse reactions (incidence at least 10%) are upper respiratory tract infection, hepatic transaminase elevation, and hypertension.” FAERS holds 428 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is fatigue (35 reports).

  • No generic listed

Check it at the source: the ponesimod FDA label on DailyMed (effective December 4, 2025, Vanda Pharmaceuticals Inc.); the FDA FAERS public dashboard.

What does the patient leaflet say about side effects?

From the patient leaflet: What are the possible side effects of PONVORY?

PONVORY may cause serious side effects, including: See " What is the most important information I should know about PONVORY? " breathing problems. Some people who take PONVORY have shortness of breath. Call your healthcare provider right away if you have new or worsening breathing problems. liver problems. PONVORY may cause liver problems. Your healthcare provider should do blood tests to check your liver before you start taking PONVORY. Call your healthcare provider right away if you have any of the following symptoms of liver problems: unexplained nausea vomiting stomach (abdominal) pain tiredness loss of appetite yellowing of the whites of your eyes or skin dark urine increased blood pressure. Your healthcare provider should check your blood pressure during treatment with PONVORY. types of skin cancer, including basal cell carcinoma, melanoma, and squamous cell carcinoma. […]

Source: FDA drug label, Vanda Pharmaceuticals Inc., effective December 4, 2025 (SPL set 0c025ba8-ba51-272e-e063-6294a90ad120), via openFDA; the full label on DailyMed

What does the label list?

From the label: adverse reactions

Most common adverse reactions (incidence at least 10%) are upper respiratory tract infection, hepatic transaminase elevation, and hypertension.

Table 3: Adverse Reactions Reported in Study 1 Occurring in at Least 2% of PONVORY-Treated Patients and at a Higher Rate Than in Patients Receiving Teriflunomide 14 mg

Adverse ReactionPONVORY N=565 (%)Teriflunomide 14 mg N=566 (%)
Upper respiratory infection a3734
Hepatic transaminase elevation b2312
Hypertension c109
Urinary tract infection65
Dyspnea51
Dizziness53
Cough42
Pain in extremity43
Somnolence32
Pyrexia21
C-reactive protein increased21
Hypercholesterolemia21
Vertigo21

Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.

From the label: adverse reactions, continued

The following serious adverse reactions are described elsewhere in labeling: Infections [see Warnings and Precautions ( 5.1 )] Bradyarrhythmia and Atrioventricular Conduction Delays [see Warnings and Precautions ( 5.2 )] Respiratory Effects [see Warnings and Precautions ( 5.3 )] Liver Injury [see Warnings and Precautions ( 5.4 )] Increased Blood Pressure [see Warnings and Precautions ( 5.5 )] Cutaneous Malignancies [see Warnings and Precautions ( 5.6 )] Fetal Risk [see Warnings and Precautions ( 5.7 )] Macular Edema [see Warnings and Precautions ( 5.8 )] Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions ( 5.9 )] Unintended Additive Immunosuppressive Effects From Prior Treatment With Immunosuppressive or Immune-Modulating Therapies [see Warnings and Precautions ( 5.10 )] Severe Increase in Disability After Stopping PONVORY [see Warnings and Precautions ( 5.11 )] Immune System Effects After Stopping PONVORY [see Warnings and Precautions ( 5.12 )] Most common adverse reactions (incidence at least 10%) are upper respiratory tract infection, hepatic transaminase elevation, and hypertension. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Vanda Pharmaceuticals, Inc. at 833-933-9331, FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …

Source: FDA drug label, Vanda Pharmaceuticals Inc., effective December 4, 2025 (SPL set 0c025ba8-ba51-272e-e063-6294a90ad120), via openFDA; the full label on DailyMed

What do FAERS reports show?

428 reports list ponesimod among the medicines taken, each a report of something that happened, not proof the medicine caused it; 1 are coded as a death and 40 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 20 reactions below, 8 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

The 25 most reported reactions

  • Product Dose Omission Issue (a use or a product term, not a reaction)75
  • Fatigue (named in the label)35
  • Dizziness (named in the label)24
  • Dyspnoea (named in the label)23
  • Headache (named in the label)22
  • Product Use Issue (a use or a product term, not a reaction)17
  • Nausea (named in the label)14
  • Covid-1913
  • Drug Ineffective (a use or a product term, not a reaction)13
  • Pain12
  • Hypoaesthesia11
  • Somnolence (named in the label)11
  • Multiple Sclerosis (a use or a product term, not a reaction)9
  • Multiple Sclerosis Relapse9
  • Abdominal Discomfort8
  • Central Nervous System Lesion8
  • Fall8
  • Therapy Interrupted (a use or a product term, not a reaction)8
  • Asthenia7
  • Gait Disturbance7
  • Hypersensitivity7
  • Hypertension (named in the label)7
  • Pain In Extremity (named in the label)7
  • Vision Blurred7
  • White Blood Cell Count Decreased7

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Ponesimod: the full record
label, generics, price, shortages, recalls
Side effects hub
the most reported medicines and reactions