What the label lists and what reports show
Methoxy polyethylene glycol-epoetin beta side effects
Methoxy polyethylene glycol-epoetin beta's FDA label: “The most common adverse reactions (≥ 10%) are hypertension, diarrhea, nasopharyngitis ( 6 ).” FAERS holds 10,973 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 drug hypersensitivity (2,981 reports).
- No generic listed
- Boxed warning
Check it at the source: the methoxy polyethylene glycol-epoetin beta FDA label on DailyMed (effective August 14, 2026, Vifor (International) 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 Mircera?Mircera may cause serious side effects, including: • See “ What is the most important information I should know about Mircera? ” • High blood pressure. High blood pressure is a common side effect of Mircera in patients with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medicine while taking Mircera. This can happen even if you have never had high blood pressure before. Your healthcare provider should check your blood pressure often. If your blood pressure does go up, your healthcare provider may prescribe new or more blood pressure medicine. • Seizures. If you have any seizures while taking Mircera, get medical help right away and tell your healthcare provider. • No response or loss of your hemoglobin response to Mircera. […]
Source: FDA drug label, BLA125164 (Hoffman-La Roche), as published by Vifor (International) Inc., effective August 14, 2026 (SPL set 22c56f2a-f73c-60e7-e054-00144ff88e88), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe most common adverse reactions (≥ 10%) are hypertension, diarrhea, nasopharyngitis ( 6 ).
A table the label prints in its adverse reactions section without a title; its column headings name the groups compared
| BODY SYSTEM Adverse Reaction | Patients Treated with Mircera (n=1789) VASCULAR |
|---|---|
| Hypertension | 13% |
| Hypotension | 5% |
| Diarrhea | 11% |
| Vomiting | 6% |
| Constipation | 5% |
| Nasopharyngitis | 11% |
| Upper Respiratory Tract Infection | 9% |
| Urinary Tract Infection | 5% |
| Headache | 9% |
| Muscle Spasms | 8% |
| Back Pain | 6% |
| Pain in Extremity | 5% |
| Procedural Hypotension | 8% |
| Arteriovenous Fistula Thrombosis | 5% |
| Arteriovenous Fistula Site Complication | 5% |
| Fluid Overload | 7% |
| Cough | 6% |
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 discussed in greater detail in other sections of the labeling: • Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see Warnings and Precautions ( 5.1 )] • Increased Mortality and/or Tumor Progression in Patients with Cancer [see Warnings and Precautions ( 5.2 )] • Hypertension [see Warnings and Precautions ( 5.3 )] • Seizures [see Warnings and Precautions ( 5.4 )] • Pure Red Cell Aplasia [see Warnings and Precautions ( 5.6 )] • Serious Allergic Reactions [see Warnings and Precautions ( 5.7 )] • Severe Cutaneous Reactions [see Warnings and Precautions ( 5.8 )] The most common adverse reactions (≥ 10%) are hypertension, diarrhea, nasopharyngitis ( 6 ). To report SUSPECTED ADVERSE REACTIONS, contact Vifor (International) Inc. at 1-800-576-8295, or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical studies of Mircera cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. Adult Patients The data described below reflect exposure to Mircera in 2737 patients, including 1451 exposed for 6 months and 1144 exposed for greater than one year. …
Source: FDA drug label, BLA125164 (Hoffman-La Roche), as published by Vifor (International) Inc., effective August 14, 2026 (SPL set 22c56f2a-f73c-60e7-e054-00144ff88e88), via openFDA; the full label on DailyMed
What do FAERS reports show?
10,973 reports list methoxy polyethylene glycol-epoetin beta among the medicines taken, each a report of something that happened, not proof the medicine caused it; 2,904 are coded as a death and 2,954 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 23 reactions below, 10 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?
- Methoxy polyethylene glycol-epoetin beta: 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