What the label lists and what reports show
Epoetin side effects
Epoetin's FDA label lists its adverse reactions in its own words. FAERS holds 33,968 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 anaemia (2,346 reports).
- No generic listed
- Boxed warning
Check it at the source: the epoetin FDA label on DailyMed (effective June 22, 2025); 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 RETACRIT?RETACRIT may cause serious side effects, including: • See " What is the most important information I should know about RETACRIT? " • High blood pressure. High blood pressure is a common side effect of RETACRIT in people with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medicine while taking RETACRIT. 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 RETACRIT, get medical help right away and tell your healthcare provider. • Antibodies to RETACRIT. Your body may make antibodies to RETACRIT. […]
Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective June 22, 2025 (SPL set 3af26b0d-8ad0-44e1-a538-8bdb5ab39374), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsThe following serious adverse reactions are discussed in greater detail in other sections of the label: • Increased Mortality, Myocardial Infarction, Stroke, and Thromboembolism [see Warnings and Precautions (5.1) ] • Increased mortality and/or increased risk of tumor progression or recurrence in Patients with Cancer [see Warnings and Precautions (5.2) ] • Hypertension [see Warnings and Precautions (5.3) ] • Seizures [see Warnings and Precautions (5.4) ] • PRCA [see Warnings and Precautions (5.6) ] • Serious allergic reactions [see Warnings and Precautions (5.7) ] • Severe Cutaneous Reactions [see Warnings and Precautions (5.8) ] • Patients with CKD: Adverse reactions in ≥ 5% of epoetin alfa-treated patients in clinical studies were hypertension, arthralgia, muscle spasm, pyrexia, dizziness, medical device malfunction, vascular occlusion, and upper respiratory tract infection ( 6.1 ). …
Table 6. Adverse Reactions in Patients with Cancer
| Adverse Reaction | Epoetin alfa (n = 168) | Placebo (n = 165) |
|---|---|---|
| Nausea | 35% | 30% |
| Vomiting | 20% | 16% |
| Myalgia | 10% | 5% |
| Arthralgia | 10% | 6% |
| Stomatitis | 10% | 8% |
| Cough | 9% | 7% |
| Weight decrease | 9% | 5% |
| Leukopenia | 8% | 7% |
| Bone pain | 7% | 4% |
| Rash | 7% | 5% |
| Hyperglycemia | 6% | 4% |
| Insomnia | 6% | 2% |
| Headache | 5% | 4% |
| Depression | 5% | 4% |
| Dysphagia | 5% | 2% |
| Hypokalemia | 5% | 3% |
| Thrombosis | 5% | 3% |
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.
Source: FDA drug label, Pfizer Laboratories Div Pfizer Inc, effective June 22, 2025 (SPL set 3af26b0d-8ad0-44e1-a538-8bdb5ab39374), via openFDA; the full label on DailyMed
What do FAERS reports show?
33,968 reports list epoetin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 7,298 are coded as a death and 12,375 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 21 reactions below, 6 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?
- Epoetin: 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