Mircera: adverse event reports filed with FDA

8,865

reports as suspect product

0% of all reports · about 482 a year

281

reports, 12 months to June 2026

722 in the 12 months before

65.8%

marked serious by the reporter

78.3% across the class

25.9%

record death among outcomes, as reported

2,292 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 Mircera reports recording the termmedian drug in erythropoiesis-stimulating agent

1. Drug hypersensitivityan allergic-type reaction to a medicine33.5%2,970
2. Deaththe patient died; cause not stated by this term16.4%1,455
3. Dyspnoeashortness of breath12.2%1,083
4. Nauseafeeling sick9%797
5. Pruritusitching8.5%756
6. Vomitingbeing sick7.2%637
7. Flushingsudden reddening or warmth of the skin5.8%511
8. Haemoglobin decreasedlow haemoglobin5.7%503
9. Feeling hotfeeling hot3.8%337
10. Unresponsive to stimuli3.8%334
11. No adverse eventno adverse event was reported3.5%308
12. Dizzinesslight-headedness or unsteadiness3%262
13. Back painback pain2.9%258
14. Rashskin rash2.8%250
15. Hypotensionlow blood pressure2.8%249
16. Aplasia pure red cell2.7%241
17. Anaemialow red blood cells2.6%232
18. Erythemaskin redness2.5%226
19. Chest painchest pain2.5%221
20. Headachehead pain2.4%217
21. Urticariahives2.4%211
22. Malaisegeneral feeling of being unwell2.3%207
23. Hyperhidrosisexcessive sweating2.1%185
24. Blood pressure increaseda raised blood pressure reading2%181
25. Inappropriate schedule of product administrationthe product was taken at the wrong times2%181
26. Blood pressure decreaseda low blood pressure reading1.9%166
27. Loss of consciousnesspassing out1.8%156
28. Hypertensionhigh blood pressure1.7%154
29. Painpain, site not specified1.6%145
30. Chest discomfortchest discomfort1.6%139

Top 30 of 620 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 9 drugs in the erythropoiesis-stimulating agent 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 66,386 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. 53.8% 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 8,865 reports.

Drugs most often listed in the same reports

Other products listed in reports where Mircera 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 erythropoiesis-stimulating agent 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 Mircera as a suspect or interacting product; reports listing it only as a concomitant medication (1,121) 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.