Darbepoetin Alfa side effects: what 53,586 FDA adverse event reports show
Drug class
Erythropoiesis-stimulating Agent
Brand names
Aranesp
Who reports
53,586 reports · 89% serious · 19,851 with death outcome · 47% female
Used for
Aranesp is an erythropoiesis-stimulating agent (ESA) indicated for the treatment of anemia due to: Chronic Kidney Disease (CKD) in patients on dialysis and patients not on dialysis ( 1.1 ). The effects of concomitant myelosuppressive chemotherapy, and upon initiation, there is a minimum of two additional months of planned chemotherapy ( 1.2 ).
What it is
Darbepoetin alfa is an erythropoiesis-stimulating protein that is produced in Chinese hamster ovary (CHO) cells by recombinant DNA technology. Darbepoetin alfa is a 165-amino acid protein that.
Boxed warning
ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE Chronic Kidney Disease: In controlled trials, patients experie.
Causality screen of the 40 strongest signals
What the badges mean
- Labeled adverse reaction The exact term appears in the label's warnings or adverse-reactions sections: a known, expected effect. The FAERS signal confirms the label rather than discovering anything.
- Labeled (related wording) The label describes this effect under different wording (e.g. 'neutropenia' for 'neutrophil count decreased'). Treated as known.
- Likely indication confounding The term appears in the label's indications: reports probably describe the disease being treated (or its progression), not a drug effect. Classic confounding by indication.
- Reporting / coding artifact An administrative, monitoring or exposure term (product issue, off-label use, 'test normal', overdose...). Not a biological reaction; a high PRR here reflects how reports are coded.
- Lab value / disease marker A laboratory result, investigation or disease-activity marker (antibody positive, CRP abnormal, swollen joint count) not described in the label. These usually mirror the monitored disease or testing protocol rather than a drug effect; not screened further.
- Not in label — unassessed Not found in the label text, not an artifact pattern. This is a genuine candidate for a formal causality assessment (Bradford Hill / WHO-UMC); it has NOT had one here.
Strongest disproportionality signals
Flagged terms (PRR ≥ 2, χ² ≥ 4, n ≥ 10), ranked by PRR; infinite PRRs (no comparator reports) excluded. The EBGM column is a second, shrinkage-based estimate (MGPS) with its 5th percentile EB05 and the BCPNN IC025; a pair flagged by PRR alone is marked PRR-only and should be read as fragile. The strata column recomputes the PRR on serious reports only (and, for the 300 most-reported drugs, adjusted for age band), and flags pairs whose reports are unusually skewed by sex or come mostly from consumers. Each row also shows the PRR against the other drugs of the same FDA class, which removes most confounding by the condition being treated, and a calibrated p-value: on validation, known non-causes average an ROR of about 2, so significance is judged against that empirical null (✓ = p < 0.05 after calibration). 1,178 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Vascular anastomotic haemorrhage | 24 | 4,621.9 1,092.3–19,556.4ROR 4,624.0 · calibrated p 1e-13 ✓ | 277.7 EB05 196.4 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=24 · ♀ 0% (drug 47%) | not reported in cached trials |
| Appendicolith | 281 | 1,151.4 911.7–1,454.0ROR 1,157.4 · calibrated p 1e-17 ✓ | 283.8 EB05 257.0 · IC025 +7.4 3/3 methods agree | Not in label — unassessed | serious n=281 · ♀ 6% (drug 47%) · 96% clinician | not reported in cached trials |
| Antacid therapy | 78 | 732.7 502.1–1,069.3ROR 733.8 · calibrated p 7e-15 ✓ | 238.4 EB05 197.2 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious n=78 · ♀ 23% (drug 47%) · 100% clinician | not reported in cached trials |
| Sleep disorder therapy | 112 | 599.1 445.7–805.5ROR 600.4 · calibrated p 3e-14 ✓ | 226.0 EB05 193.0 · IC025 +6.5 3/3 methods agree | Reporting / coding artifact | serious n=112 · ♀ 0% (drug 47%) · 100% clinician | NCT00093015: 2/2,004 (0.1%) on Darbepoetin Alfa (serious AE) |
| Shunt stenosis | 134 | 360.9 285.2–456.8ROR 361.8 · calibrated p 3e-12 ✓ | 182.0 EB05 157.6 · IC025 +6.5 3/3 methods agree | Not in label — unassessed | serious n=134 · 100% clinician | not reported in cached trials |
| Anti-erythropoietin antibody positive | 120 | 352.8 275.5–451.9ROR 353.6 · calibrated p 4e-12 ✓ | 179.4 EB05 154.0 · IC025 +6.4 3/3 methods agree | Lab value / disease marker | serious n=119 · 95% clinician | not reported in cached trials |
| Analgesic therapy | 124 | 266.8 212.2–335.4ROR 267.4 · calibrated p 5e-11 ✓ | 154.3 EB05 132.8 · IC025 +6.3 3/3 methods agree | Reporting / coding artifact | serious n=124 · ♀ 14% (drug 47%) · 95% clinician | not reported in cached trials |
| Arteriovenous fistula site complication | 238 | 255.3 216.8–300.7ROR 256.5 · calibrated p 5e-11 ✓ | 152.1 EB05 136.5 · IC025 +6.7 3/3 methods agree | Reporting / coding artifact | serious n=238 · 97% clinician | NCT00093015: 1/2,004 (0.0%) on Darbepoetin Alfa (serious AE) |
| Drug therapy | 121 | 239.0 190.5–299.8ROR 239.5 · calibrated p 1e-10 ✓ | 144.5 EB05 124.2 · IC025 +6.2 3/3 methods agree | Reporting / coding artifact | serious n=121 · ♀ 15% (drug 47%) · 95% clinician | NCT00093015: 7/2,004 (0.3%) on Darbepoetin Alfa; 4/2,019 (0.2%) control (serious AE) |
| Vena cava injury | 26 | 161.5 102.2–255.3ROR 161.6 · calibrated p 1e-8 ✓ | 105.5 EB05 75.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=26 · ♀ 0% (drug 47%) | not reported in cached trials |
| Anticoagulant therapy | 80 | 158.8 122.4–206.0ROR 159.1 · calibrated p 5e-9 ✓ | 109.9 EB05 91.1 · IC025 +5.7 3/3 methods agree | Reporting / coding artifact | serious n=80 · ♀ 24% (drug 47%) · 100% clinician | not reported in cached trials |
| Heart failure with preserved ejection fraction | 70 | 143.4 109.0–188.7ROR 143.6 · calibrated p 1e-8 ✓ | 101.9 EB05 83.4 · IC025 +5.5 3/3 methods agree | Not in label — unassessed | serious n=70 · ♀ 100% (drug 47%) | not reported in cached trials |
| Malignant melanoma stage 0 | 46 | 133.2 95.3–186.3ROR 133.3 · calibrated p 3e-8 ✓ | 95.4 EB05 74.4 · IC025 +5.1 3/3 methods agree | Not in label — unassessed | serious n=46 · ♀ 0% (drug 47%) · 100% clinician | not reported in cached trials |
| Congenital hiatus hernia | 55 | 129.2 95.2–175.3ROR 129.3 · calibrated p 3e-8 ✓ | 93.9 EB05 74.9 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=55 · ♀ 0% (drug 47%) · 100% clinician | not reported in cached trials |
| Anti-erythropoietin antibody negative | 22 | 122.8 76.0–198.4ROR 122.9 · calibrated p 1e-7 ✓ | 86.6 EB05 60.3 · IC025 +4.2 3/3 methods agree | Reporting / coding artifact | serious n=22 | not reported in cached trials |
| Aplasia pure red cell | 808 | 120.3 111.2–130.1ROR 122.1 · calibrated p 3e-8 ✓ | 91.7 EB05 86.5 · IC025 +6.3 3/3 methods agree | Labeled (related wording) related wording | serious n=807 · 96% clinician | not reported in cached trials |
| Shunt occlusion | 106 | 103.6 83.6–128.4ROR 103.8 · calibrated p 1e-7 ✓ | 80.7 EB05 68.6 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=106 · 100% clinician | not reported in cached trials |
| Peritoneal dialysis | 174 | 103.4 87.5–122.2ROR 103.8 · calibrated p 1e-7 ✓ | 81.0 EB05 71.4 · IC025 +5.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=174 | NCT02876835: 2/1,933 (0.1%) on Darbepoetin Alfa (serious AE) |
| Central nervous system lupus | 42 | 94.1 67.1–131.8ROR 94.1 · calibrated p 4e-7 ✓ | 73.4 EB05 56.6 · IC025 +4.8 3/3 methods agree | Labeled (related wording) related wording | serious n=42 · ♀ 100% (drug 47%) | not reported in cached trials |
| Arteriovenous fistula site infection | 25 | 88.3 57.2–136.4ROR 88.4 · calibrated p 9e-7 ✓ | 68.4 EB05 48.7 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=25 | NCT00093015: 2/2,004 (0.1%) on Darbepoetin Alfa; 1/2,019 (0.0%) control (serious AE) |
| Body mass index abnormal | 42 | 87.0 62.2–121.5ROR 87.0 · calibrated p 6e-7 ✓ | 69.0 EB05 53.2 · IC025 +4.8 3/3 methods agree | Lab value / disease marker | serious n=42 · ♀ 100% (drug 47%) | not reported in cached trials |
| Arteriovenous fistula operation | 49 | 86.6 63.5–118.0ROR 86.7 · calibrated p 6e-7 ✓ | 69.0 EB05 54.3 · IC025 +4.9 3/3 methods agree | Reporting / coding artifact | serious n=48 · 100% clinician | not reported in cached trials |
| Renal cyst haemorrhage | 39 | 84.4 59.7–119.3ROR 84.4 · calibrated p 8e-7 ✓ | 67.2 EB05 51.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=39 · ♀ 0% (drug 47%) | NCT02876835: 2/1,933 (0.1%) on Darbepoetin Alfa (serious AE) |
| Investigation | 491 | 71.5 65.0–78.7ROR 72.2 · calibrated p 1e-6 ✓ | 60.3 EB05 56.0 · IC025 +5.7 3/3 methods agree | Lab value / disease marker | serious n=491 · 98% clinician | not reported in cached trials |
| Bacteroides infection | 38 | 67.1 47.6–94.7ROR 67.2 · calibrated p 4e-6 ✓ | 55.8 EB05 42.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=38 · ♀ 0% (drug 47%) · 100% clinician | not reported in cached trials |
| Reticulocyte count decreased | 62 | 64.7 49.5–84.7ROR 64.8 · calibrated p 4e-6 ✓ | 54.7 EB05 44.2 · IC025 +4.9 3/3 methods agree | Lab value / disease marker | serious n=58 · 100% clinician | not reported in cached trials |
| Transplant | 316 | 60.0 53.3–67.5ROR 60.3 · calibrated p 4e-6 ✓ | 51.9 EB05 47.3 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=316 | NCT02876835: 1/1,933 (0.1%) on Darbepoetin Alfa (serious AE) |
| Mineral supplementation | 55 | 55.2 41.6–73.2ROR 55.2 · calibrated p 1e-5 ✓ | 47.6 EB05 38.0 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious n=55 | not reported in cached trials |
| Refractory cytopenia with unilineage dysplasia | 24 | 53.1 34.7–81.4ROR 53.1 · calibrated p 2e-5 ✓ | 45.2 EB05 32.0 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=24 · 100% clinician | not reported in cached trials |
| Haemodialysis | 989 | 51.5 48.2–55.0ROR 52.5 · calibrated p 1e-5 ✓ | 45.5 EB05 43.2 · IC025 +5.4 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 29.9 | NCT02876835: 2/1,933 (0.1%) on Darbepoetin Alfa (serious AE) |
| Arteriovenous fistula thrombosis | 38 | 47.8 34.1–67.0ROR 47.9 · calibrated p 3e-5 ✓ | 41.8 EB05 31.8 · IC025 +4.3 3/3 methods agree | Labeled (related wording) related wording | serious n=38 · 100% clinician | NCT02876835: 9/1,933 (0.5%) on Darbepoetin Alfa (serious AE) |
| Skin fibrosis | 44 | 39.2 28.8–53.5ROR 39.3 · calibrated p 8e-5 ✓ | 35.2 EB05 27.3 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=44 | not reported in cached trials |
| Abdominal wall haemorrhage | 23 | 38.2 24.9–58.6ROR 38.2 · calibrated p 1e-4 ✓ | 33.9 EB05 23.8 · IC025 +3.6 3/3 methods agree | Labeled (related wording) related wording | serious n=23 · ♀ 0% (drug 47%) | not reported in cached trials |
| Hyperphosphataemia | 186 | 37.6 32.3–43.7ROR 37.7 · calibrated p 8e-5 ✓ | 34.2 EB05 30.3 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=185 · ♀ 20% (drug 47%) · 95% clinician | NCT00093015: 1/2,019 (0.0%) control (serious AE) |
| Transformation to acute myeloid leukaemia | 56 | 36.4 27.7–47.8ROR 36.4 · calibrated p 1e-4 ✓ | 33.0 EB05 26.3 · IC025 +4.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=56 · 100% clinician | not reported in cached trials |
| Intraductal papillary mucinous neoplasm | 24 | 35.0 23.1–53.2ROR 35.0 · calibrated p 2e-4 ✓ | 31.5 EB05 22.2 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 0% (drug 47%) | not reported in cached trials |
| Blood phosphorus increased | 220 | 34.3 29.9–39.4ROR 34.4 · calibrated p 1e-4 ✓ | 31.5 EB05 28.2 · IC025 +4.7 3/3 methods agree | Lab value / disease marker | serious n=216 · ♀ 16% (drug 47%) · 93% clinician | not reported in cached trials |
| Serositis | 44 | 33.9 24.9–46.1ROR 33.9 · calibrated p 2e-4 ✓ | 30.9 EB05 23.9 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=44 · ♀ 100% (drug 47%) | not reported in cached trials |
| Sars-cov-2 antibody test positive | 21 | 32.7 21.0–51.1ROR 32.8 · calibrated p 3e-4 ✓ | 29.5 EB05 20.4 · IC025 +3.4 3/3 methods agree | Lab value / disease marker | serious n=21 | not reported in cached trials |
| Vascular compression | 24 | 32.7 21.5–49.5ROR 32.7 · calibrated p 3e-4 ✓ | 29.6 EB05 20.9 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=24 · ♀ 0% (drug 47%) | not reported in cached trials |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Darbepoetin Alfa as a study intervention. The right-hand column of the signal table shows whether each FAERS term was also recorded in these trials, with a real denominator (10 of 40 signal terms matched).
- NCT00093015 — Trial to Reduce Cardiovascular Events With Aranesp® Therapy (TREAT) (N=4038, PHASE3; 990 AE terms posted; arms: Placebo; Darbepoetin Alfa)
- NCT02876835 — Anemia Studies in Chronic Kidney Disease: Erythropoiesis Via a Novel Prolyl Hydroxylase Inhibitor Daprodustat- (N=3872, PHASE3; 770 AE terms posted; arms: Run-in Period: Placebo; Daprodustat; Darbepoetin Alfa)
Caveats: trial populations, doses and follow-up differ from the reporting population; AE terms are sponsor-coded and matched here by wording; absence from a trial list means the term was not reported above the sponsor's frequency threshold, not that it cannot occur.
Most frequently reported reactions
By raw co-report count, regardless of disproportionality. Common terms here are often the illness itself or generic outcomes.
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Death | 16,130 | 7.5 7.4–7.5ROR 10.2 · calibrated p 0.030 ✓ | 7.3 EB05 7.2 · IC025 +2.8 3/3 methods agree | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 4.7 | NCT00093015: 1/2,019 (0.0%) control (serious AE) |
| Hospitalisation | 6,181 | 16.5 16.1–16.9ROR 18.5 · calibrated p 0.003 ✓ | 15.9 EB05 15.5 · IC025 +3.9 3/3 methods agree | Reporting / coding artifact | serious PRR 10.5 | NCT00093015: 1/2,004 (0.0%) on Darbepoetin Alfa (serious AE) |
| Off label use (used outside approved label) | 2,583 | 1.2 1.1–1.2ROR 1.2 · calibrated p 0.422 | 1.2 EB05 1.1 · IC025 +0.2 | Reporting / coding artifact | serious PRR 1.0 | not reported in cached trials |
| Anaemia (low red blood cells) | 2,161 | 4.5 4.3–4.7ROR 4.6 · calibrated p 0.281 | 4.4 EB05 4.3 · IC025 +2.1 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 3.0 | NCT00093015: 65/2,004 (3.2%) on Darbepoetin Alfa; 155/2,019 (7.7%) control (serious AE) |
| Haemoglobin decreased | 1,646 | 6.3 6.0–6.7ROR 6.5 · calibrated p 0.121 | 6.2 EB05 6.0 · IC025 +2.6 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 3.9 | NCT00093015: 1/2,004 (0.0%) on Darbepoetin Alfa (serious AE) |
| Product storage error | 1,623 | 7.5 7.1–7.8ROR 7.7 · calibrated p 0.076 | 7.3 EB05 7.0 · IC025 +2.8 3/3 methods agree | Reporting / coding artifact | serious PRR 1.5 | not reported in cached trials |
| Pneumonia (lung infection) | 1,481 | 1.8 1.7–1.9ROR 1.8 · calibrated p 0.841 | 1.8 EB05 1.7 · IC025 +0.8 | Labeled (related wording) related wording | serious PRR 1.2 | NCT00093015: 9/2,004 (0.4%) on Darbepoetin Alfa; 13/2,019 (0.6%) control (serious AE) |
| Fatigue (tiredness) | 1,469 | 0.7 0.7–0.8ROR 0.7 · calibrated p 0.147 | 0.7 EB05 0.7 · IC025 -0.5 PRR-only: not supported by EBGM or IC | Likely indication confounding term in indications | serious PRR 0.8 | NCT00093015: 1/2,004 (0.0%) on Darbepoetin Alfa; 2/2,019 (0.1%) control (serious AE) |
| Dyspnoea (shortness of breath) | 1,432 | 1.0 0.9–1.0ROR 1.0 · calibrated p 0.300 | 1.0 EB05 0.9 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Labeled adverse reaction exact term | serious PRR 0.8 | NCT00093015: 10/2,004 (0.5%) on Darbepoetin Alfa; 10/2,019 (0.5%) control (serious AE) |
| Diarrhoea (diarrhea) | 1,324 | 0.8 0.8–0.8ROR 0.8 · calibrated p 0.184 | 0.8 EB05 0.8 · IC025 -0.4 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.8 | NCT00093015: 11/2,004 (0.5%) on Darbepoetin Alfa; 7/2,019 (0.3%) control (serious AE) |
| Nausea | 1,285 | 0.6 0.6–0.7ROR 0.6 · calibrated p 0.097 | 0.6 EB05 0.6 · IC025 -0.7 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.7 | NCT00093015: 3/2,004 (0.1%) on Darbepoetin Alfa; 4/2,019 (0.2%) control (serious AE) |
| Fall | 1,211 | 1.4 1.3–1.5ROR 1.4 · calibrated p 0.600 | 1.4 EB05 1.4 · IC025 +0.4 | Not in label — unassessed | serious PRR 1.1 | NCT00093015: 5/2,004 (0.2%) on Darbepoetin Alfa; 6/2,019 (0.3%) control (serious AE) |
| Asthenia (weakness) | 1,140 | 1.2 1.1–1.3ROR 1.2 · calibrated p 0.434 | 1.2 EB05 1.1 · IC025 +0.1 | Not in label — unassessed | serious PRR 1.0 | NCT00093015: 9/2,004 (0.4%) on Darbepoetin Alfa; 9/2,019 (0.4%) control (serious AE) |
| Vomiting | 1,122 | 0.9 0.9–1.0ROR 0.9 · calibrated p 0.265 | 0.9 EB05 0.9 · IC025 -0.2 PRR-only: not supported by EBGM or IC | Not in label — unassessed | serious PRR 0.9 | NCT00093015: 7/2,004 (0.3%) on Darbepoetin Alfa; 8/2,019 (0.4%) control (serious AE) |
| Circumstance or information capable of leading to medication error | 1,052 | 12.6 11.9–13.4ROR 12.9 · calibrated p 0.013 ✓ | 12.3 EB05 11.6 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
Unlabeled candidate signals
These flagged terms were not found in the FDA label text and do not match an artifact pattern. They are the pairs that would merit a structured assessment (temporality, dose-response, biological plausibility, consistency across databases, trial or cohort evidence). The screen has not done that; string-matching misses label wording, and a strong PRR can still be stimulated reporting, co-medication, or the disease itself.
- Appendicolith — n=281, PRR 1,151.4
- Shunt stenosis — n=134, PRR 360.9
- Vena cava injury — n=26, PRR 161.5
- Heart failure with preserved ejection fraction — n=70, PRR 143.4
- Malignant melanoma stage 0 — n=46, PRR 133.2
- Congenital hiatus hernia — n=55, PRR 129.2
- Shunt occlusion — n=106, PRR 103.6
- Renal cyst haemorrhage — n=39, PRR 84.4 (also seen in trial arm)
- Bacteroides infection — n=38, PRR 67.1
- Transplant — n=316, PRR 60.0 (also seen in trial arm)
✓ A hand-written Bradford Hill causality assessment exists for this drug: Erythropoiesis-stimulating agents (darbepoetin alfa) ↔ Mortality / cardiovascular risk.
Want to assess one of these properly? The runbook describes the Bradford Hill / trial-evidence workflow used on the assessment page, and handoff_top1000_signals.csv lists the strongest unassessed pairs across all drugs.
Common questions
What are the most reported side effects of Darbepoetin Alfa?
In FDA FAERS, the most frequently co-reported reaction terms for Darbepoetin Alfa are anaemia, haemoglobin decreased, pneumonia, fatigue, dyspnoea, diarrhoea. These are report counts, not rates: FAERS has no denominator, reporting is voluntary and uneven, and a term can be reported because of the illness being treated rather than the drug.
Does Darbepoetin Alfa have an FDA boxed warning?
Yes. The current FDA label carries a boxed warning: ESAs INCREASE THE RISK OF DEATH, MYOCARDIAL INFARCTION, STROKE, VENOUS THROMBOEMBOLISM, THROMBOSIS OF VASCULAR ACCESS AND TUMOR PROGRESSION OR RECURRENCE Chronic Kidney Disease: In controlled trials, patients experie.
Do FAERS signals prove that Darbepoetin Alfa causes these side effects?
No. A disproportionality signal (PRR, ROR) means a reaction is reported more often with this drug than with others in the database. That can reflect a real effect, but also the disease being treated, stimulated reporting after news or litigation, co-medications, or how reports are coded. Causality needs temporality, dose-response, biological plausibility, consistency across data sources and, ideally, trial or cohort evidence. This page screens each term against the FDA label and ClinicalTrials.gov results; it does not establish causation.
Sources & methods
- FDA label via openFDA (set ID 0fd36cb9-c4f6-4167-93c9-8530865db3f9, effective 20260707; matched on
openfda.generic_name.exact:"DARBEPOETIN ALFA") - Bayesian shrinkage measures computed offline over all 1,317,300 cached pairs: BCPNN information component (IC, with Norén closed-form IC025) and MGPS empirical-Bayes geometric mean (EBGM, EB05) with a two-component gamma prior fitted by maximum marginal likelihood (α₁=0.57, β₁=0.02, α₂=1.42, β₂=0.70, w=0.17); unstratified
- FAERS pair statistics from the OpenPV build of 2026-09-14 (openFDA
count=aggregation, fieldpatient.drug.openfda.generic_name.exact, 1,218 reaction terms, min 3 co-reports); PRR/ROR with 95% CI, chi-square with Yates correction - Serious-only and stratified counts (serious:1, patient.patientsex, primarysource.qualification) from openFDA count queries; serious-only PRR uses the drug serious report total and the term global serious total (N_serious=11,882,979); strata shown only when n ≥ 20
- Seriousness and sex counts from openFDA
count=serious,patient.patientsex,seriousnessdeath - ClinicalTrials.gov API v2 (query
DARBEPOETIN ALFA, results-bearing studies sorted by enrollment)
Page generated 2026-10-14. Label and PubChem text are retrieved automatically and may lag the current label; always check the current prescribing information. OpenPV is a beta research tool of the Open Source Medicine Foundation.