What the label lists and what reports show
Siponimod side effects
Siponimod's FDA label: “Most common adverse reactions (incidence greater than 10%) are headache, hypertension, and transaminase increases.” FAERS holds 8,869 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 (993 reports).
- No generic listed
Check it at the source: the siponimod FDA label on DailyMed (effective June 30, 2026, Novartis Pharmaceuticals Corporation); 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 MAYZENT?MAYZENT may cause serious side effects, including: See "What is the most important information I should know about MAYZENT?" Breathing problems. Some people who take MAYZENT have shortness of breath. Call your healthcare provider right away if you have new or worsening breathing problems. Liver problems. MAYZENT may cause liver problems. Your healthcare provider should do blood tests to check your liver before you start taking MAYZENT. Call your healthcare provider right away if you have any of the following symptoms of liver problems: nausea vomiting stomach pain tiredness loss of appetite your skin or the whites of your eyes turn yellow dark urine Types of skin cancer, including basal cell carcinoma, melanoma, and squamous cell carcinoma. […]
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective June 30, 2026 (SPL set 44492772-5aed-4627-bd85-e8e89f308bb3), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence greater than 10%) are headache, hypertension, and transaminase increases.
Table 3 Adverse Reactions Reported in Study 1 (Occurring in at Least 5% of MAYZENT-Treated Patients and at a Rate at Least 1% Higher Than in Patients Receiving Placebo)
| Adverse reaction | MAYZENT 2 mg (N = 1099) % | Placebo (N = 546) % |
|---|---|---|
| Headache a | 15 | 14 |
| Hypertension b | 13 | 9 |
| Transaminase increased c | 11 | 3 |
| Falls | 11 | 10 |
| Edema peripheral d | 8 | 4 |
| Nausea | 7 | 4 |
| Dizziness | 7 | 5 |
| Diarrhea | 6 | 4 |
| Bradycardia e | 6 | 3 |
| Pain in extremity f | 6 | 4 |
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, continuedThe following serious adverse reactions are described elsewhere in the labeling: Infections [see Warnings and Precautions (5.1)] Progressive Multifocal Leukoencephalopathy [see Warnings and Precautions (5.2)] Macular Edema [see Warnings and Precautions (5.3)] Bradyarrhythmia and Atrioventricular Conduction Delays [see Warnings and Precautions (5.4)] Respiratory Effects [see Warnings and Precautions (5.5)] Liver Injury [see Warnings and Precautions (5.6)] Cutaneous Malignancies [see Warnings and Precautions (5.7)] Hypersensitivity [see Warnings and Precautions (5.8)] Increased Blood Pressure [see Warnings and Precautions (5.9)] Fetal Risk [see Warnings and Precautions (5.10)] Posterior Reversible Encephalopathy Syndrome [see Warnings and Precautions (5.11)] Unintended Additive Immunosuppressive Effects From Prior Treatment With Immunosuppressive or Immune-Modulating Therapies [see Warnings and Precautions (5.12)] Severe Increase in Disability After Stopping MAYZENT [see Warnings and Precautions (5.13)] Immune System Effects After Stopping MAYZENT [see Warnings and Precautions (5.14)] Most common adverse reactions (incidence greater than 10%) are headache, hypertension, and transaminase increases.
Source: FDA drug label, Novartis Pharmaceuticals Corporation, effective June 30, 2026 (SPL set 44492772-5aed-4627-bd85-e8e89f308bb3), via openFDA; the full label on DailyMed
What do FAERS reports show?
8,869 reports list siponimod among the medicines taken, each a report of something that happened, not proof the medicine caused it; 207 are coded as a death and 1,463 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. Reports rose sharply in 2020 (2,147, against a median of 507 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 22 reactions below, 7 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.
Reports received each year
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Siponimod: the full record
- label, generics, price, shortages, recalls
- Report a side effect to the FDA
- MedWatch
- Side effects hub
- the most reported medicines and reactions