Mayzent: adverse event reports filed with FDA

8,222

reports as suspect product

0% of all reports · about 606 a year

251

reports, 12 months to June 2026

341 in the 12 months before

47.1%

marked serious by the reporter

49.1% across the class

2.1%

record death among outcomes, as reported

176 reports · not verified by FDA

Reports by month, five years

Reports by the month FDA received them. FDA releases FAERS data quarterly, so the newest months are incomplete and grow in later releases.

By year received

2026 covers reports received through June 2026 only.

Reactions recorded in the reports

share of Mayzent reports recording the termmedian drug in sphingosine 1-phosphate receptor modulator

1. Fatiguetiredness11.4%941
2. Headachehead pain10.3%850
3. Dizzinesslight-headedness or unsteadiness7.8%642
4. Multiple sclerosis relapsea flare of multiple sclerosis6.2%507
5. Gait disturbancedifficulty walking5.8%474
6. Falla fall5.7%471
7. Multiple sclerosis5.3%434
8. Nauseafeeling sick5%412
9. Lymphocyte count decreased4.8%397
10. Drug ineffectivethe medicine did not work as expected4.8%391
11. Product dose omission issuea dose was missed4.7%383
12. Astheniaweakness or lack of energy4.2%344
13. Covid-19COVID-19 infection4.2%343
14. Urinary tract infectionbladder or urinary infection4.2%343
15. Painpain, site not specified3.9%322
16. Malaisegeneral feeling of being unwell3.6%299
17. Balance disorderproblems with balance3.6%295
18. Memory impairmentmemory problems3.5%291
19. Hypoaesthesianumbness3.5%289
20. Feeling abnormalfeeling odd or not right3.4%281
21. Hypertensionhigh blood pressure3.3%269
22. White blood cell count decreasedlow white cell count3.2%265
23. Visual impairmentreduced vision3.1%254
24. Pain in extremitypain in an arm or leg2.9%242
25. Heart rate decreased2.9%241
26. Dyspnoeashortness of breath2.8%234
27. Peripheral swellingswelling of the arms or legs2.8%234
28. Muscular weaknessmuscle weakness2.7%219
29. Vision blurredblurred vision2.7%218
30. Diarrhoealoose or frequent stools2.4%199

Top 30 of 830 MedDRA preferred terms recorded across these reports, with a plain-language gloss where one is available. One report can record several terms. The hollow bar is the median share across the 6 drugs in the sphingosine 1-phosphate receptor modulator class; it describes the reports, not the patients. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Outcomes recorded

Outcome flags as the reporter set them; a report can carry several, and "other serious" is FDA's own category for serious reports outside the named outcomes. Grey bar: all 103,701 reports in the class. FDA has not verified any outcome and states that the reports "cannot be used to estimate the incidence of these events."

Patients and reporters

Age and sex as stated in the report; the reporter's qualification is the primary source recorded by FDA. 75.3% of reports give the United States as the country of the event or reporter.

Reason for use recorded

The indication field is filled in by the reporter and is often blank; shares are of all 8,222 reports.

Drugs most often listed in the same reports

Other products listed in reports where Mayzent is a suspect product, whatever their own role. Co-listing means the two were recorded together; it says nothing about either product's part in the event. Only the 2,500 most-reported names are counted here.

In context

Shares are of reports, not of patients treated. The number of people taking a product is not in the data, so none of these figures is a rate, and differences between columns reflect who takes a product, who reports and how long it has been sold. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic."

Other drugs in the sphingosine 1-phosphate receptor modulator class

Ordered by report count for navigation only. FDA states that adverse event reports "represent a small percentage of total usage numbers of a product", that "common products may have a higher number of adverse events due to the higher total number of people using the product", and that the data "by themselves are not an indicator of the safety profile of the drug or biologic." A brand and its generic are separate rows because reporters name them separately.

Where this comes from. Counts are built from the openFDA Drug Adverse Event (FAERS) bulk export released 28 Sep 2026, which holds reports FDA received through 30 Jun 2026. Drug names are as reported, resolved to the brand or generic name on the FDA label where openFDA's harmonisation matched them; classes are the pharmacologic class (EPC) from the label and the National Drug Code Directory of 17 Sep 2026. A report counts here when it lists Mayzent as a suspect or interacting product; reports listing it only as a concomitant medication (104) are excluded. No report narrative, lot number, patient detail or reporter identity is published. See the methodology and sources; FDA's record is authoritative, and corrections are handled within five working days.