Ultomiris: adverse event reports filed with FDA

11,279

reports as suspect product

0.1% of all reports · about 765 a year

1,816

reports, 12 months to June 2026

3,265 in the 12 months before

47.8%

marked serious by the reporter

58.7% across the class

6.5%

record death among outcomes, as reported

732 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 Ultomiris reports recording the termmedian drug in complement inhibitor

1. Fatiguetiredness13.6%1,531
2. Astheniaweakness or lack of energy6.7%757
3. Headachehead pain5.9%669
4. Drug ineffectivethe medicine did not work as expected5.4%612
5. Off label useused for a purpose or in a way not on the label4.2%471
6. Deaththe patient died; cause not stated by this term3.9%435
7. Muscular weaknessmuscle weakness3.9%435
8. Dyspnoeashortness of breath3.8%431
9. Malaisegeneral feeling of being unwell3.4%388
10. Myasthenia gravis3.4%388
11. Haemoglobin decreasedlow haemoglobin3.2%359
12. Painpain, site not specified3%333
13. Back painback pain2.9%330
14. Feeling abnormalfeeling odd or not right2.8%315
15. Therapeutic response shortened2.8%313
16. Diplopiadouble vision2.8%311
17. Nauseafeeling sick2.6%292
18. Haemolysis2.6%290
19. Diarrhoealoose or frequent stools2.6%288
20. Arthralgiajoint pain2.4%270
21. Dysphagiadifficulty swallowing2.1%242
22. Dizzinesslight-headedness or unsteadiness2.1%237
23. Gait disturbancedifficulty walking2.1%235
24. Covid-19COVID-19 infection2.1%234
25. Eyelid ptosis2.1%232
26. Symptom recurrence2%227
27. Pain in extremitypain in an arm or leg2%220
28. Pyrexiafever1.9%213
29. Nasopharyngitisa cold1.8%208
30. Falla fall1.8%207

Top 30 of 1,117 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 complement inhibitor 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 69,459 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. 81.1% 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 11,279 reports.

Drugs most often listed in the same reports

Other products listed in reports where Ultomiris 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 complement inhibitor 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 Ultomiris as a suspect or interacting product; reports listing it only as a concomitant medication (142) 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.