What the label lists and what reports show
Darbepoetin alfa side effects
Darbepoetin alfa's FDA label: “In these studies, the most frequently reported serious adverse reactions with Aranesp were hypertension and convulsions.” FAERS holds 53,587 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 (2,165 reports).
- No generic listed
- Boxed warning
Check it at the source: the darbepoetin alfa FDA label on DailyMed (effective July 7, 2026, Amgen, 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 Aranesp?Aranesp may cause serious side effects, including: See “ What is the most important information I should know about Aranesp? ” High blood pressure. High blood pressure is a common side effect of Aranesp in people with chronic kidney disease. Your blood pressure may go up or be difficult to control with blood pressure medicine while taking Aranesp. 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 Aranesp, get medical help right away and tell your healthcare provider. Antibodies to Aranesp. Your body may make antibodies to Aranesp. These antibodies can block or lessen your body’s ability to make RBCs and cause you to have severe anemia. […]
Source: FDA drug label, Amgen, Inc, effective July 7, 2026 (SPL set 0fd36cb9-c4f6-4167-93c9-8530865db3f9), via openFDA; the full label on DailyMed
What does the label list?
From the label: adverse reactionsIn these studies, the most frequently reported serious adverse reactions with Aranesp were hypertension and convulsions.
Table 5. Adverse Reactions Occurring in ≥ 5% of Patients with CKD
| Adverse Reaction | Patients Treated w ith Aranesp (n = 766) |
|---|---|
| Hypertension | 31% |
| Dyspnea | 17% |
| Peripheral edema | 17% |
| Cough | 12% |
| Procedural hypotension | 10% |
| Angina pectoris | 8% |
| Vascular access complications | 8% |
| Fluid overload | 7% |
| Rash/Erythema | 5% |
| Arteriovenous graft thrombosis | 5% |
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 clinically significant 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 )] 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 )] Patients with CKD: Adverse reactions in ≥ 10% of Aranesp-treated patients in clinical studies were hypertension, dyspnea, peripheral edema, cough, and procedural hypotension ( 6.1 ). Patients with Cancer Receiving Chemotherapy: Adverse reactions in ≥ 1% of Aranesp-treated patients in clinical studies were abdominal pain, edema, and thrombovascular events ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Amgen Medical Information at 1-800-77-AMGEN (1-800-772-6436) or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. …
Source: FDA drug label, Amgen, Inc, effective July 7, 2026 (SPL set 0fd36cb9-c4f6-4167-93c9-8530865db3f9), via openFDA; the full label on DailyMed
What do FAERS reports show?
53,587 reports list darbepoetin alfa among the medicines taken, each a report of something that happened, not proof the medicine caused it; 19,851 are coded as a death and 23,976 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. Reports rose sharply in 2017 (7,062, against a median of 1,680 a year): FAERS counts follow reporting, which news, litigation and label changes can drive, not how often a reaction happens. Of the 19 reactions below, 4 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?
- Darbepoetin alfa: 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