Epoetin Alfa side effects: what 11,775 FDA adverse event reports show
Drug class
Erythropoiesis-stimulating agent (esa)
Brand names
Epogen
Who reports
11,775 reports · 72% serious · 1,874 with death outcome · 49% female
Used for
Epogen is an erythropoiesis-stimulating agent (ESA) indicated for: Treatment of anemia due to: - Chronic Kidney Disease (CKD) in patients on dialysis and not on dialysis ( 1.1 ). - Zidovudine in patients with Human Immunodeficiency Virus (HIV) infection ( 1.2 ).
What it is
Epoetin alfa is a 165-amino acid erythropoiesis-stimulating glycoprotein manufactured by recombinant DNA technology. It has a molecular weight of approximately 30,400 daltons and is produced by mammalian cells into which the human erythropoietin gene has been introduced.
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 with ch.
Causality screen of the 40 strongest signals
What the badges mean
- 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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 1,054 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 |
|---|---|---|---|---|---|---|
| Anti-erythropoietin antibody negative | 42 | 1,505.2 997.2–2,272.0ROR 1,510.6 · χ² 33,190 / p <1e-300 | 591.2 EB05 455.8 · IC025 +5.8 3/3 methods agree | Reporting / coding artifact | serious n=42 | not reported in cached trials |
| Anti-erythropoietin antibody positive | 93 | 1,033.6 800.5–1,334.6ROR 1,041.8 · χ² 59,745 / p <1e-300 | 573.7 EB05 482.3 · IC025 +6.8 3/3 methods agree | Lab value / disease marker | serious n=93 · 97% clinician | not reported in cached trials |
| Non-neutralising antibodies positive | 15 | 1,013.1 536.7–1,912.2ROR 1,014.4 · χ² 8,986 / p <1e-300 | 353.0 EB05 227.0 · IC025 +4.0 3/3 methods agree | Lab value / disease marker | serious n=15 | not reported in cached trials |
| Peau d'orange | 26 | 691.8 439.6–1,088.7ROR 693.3 · χ² 12,375 / p <1e-300 | 363.5 EB05 260.7 · IC025 +4.9 3/3 methods agree | Not in label — unassessed | serious n=25 | NCT02876835: 1/1,937 (0.1%) on Epoetin Alfa (serious AE) |
| Skin fibrosis | 102 | 478.9 385.0–595.7ROR 483.1 · χ² 37,848 / p <1e-300 | 351.6 EB05 298.0 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=99 | not reported in cached trials |
| Nephrogenic systemic fibrosis | 530 | 373.6 340.8–409.6ROR 391.2 · χ² 162,125 / p <1e-300 | 304.9 EB05 283.7 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious n=528 | not reported in cached trials |
| Device interaction | 39 | 345.9 245.5–487.4ROR 347.0 · χ² 10,918 / p <1e-300 | 253.3 EB05 193.3 · IC025 +5.4 3/3 methods agree | Reporting / coding artifact | serious n=39 · ♀ 0% (drug 49%) | not reported in cached trials |
| Shunt stenosis | 31 | 221.3 152.4–321.4ROR 221.9 · χ² 5,843 / p <1e-300 | 175.5 EB05 129.5 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious n=31 · 100% clinician | not reported in cached trials |
| Congenital nail disorder | 13 | 209.4 117.9–372.1ROR 209.7 · χ² 2,227 / p <1e-300 | 147.2 EB05 91.6 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=13 | not reported in cached trials |
| Skin induration | 204 | 195.3 169.2–225.5ROR 198.8 · χ² 35,321 / p <1e-300 | 173.0 EB05 154.0 · IC025 +6.7 3/3 methods agree | Not in label — unassessed | serious n=202 | not reported in cached trials |
| Extremity contracture | 61 | 187.3 143.9–243.7ROR 188.2 · χ² 10,045 / p <1e-300 | 160.9 EB05 129.8 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=60 | not reported in cached trials |
| Joint contracture | 98 | 178.9 145.4–220.0ROR 180.4 · χ² 15,573 / p <1e-300 | 157.5 EB05 133.0 · IC025 +6.1 3/3 methods agree | Not in label — unassessed | serious n=98 | not reported in cached trials |
| Aplasia pure red cell | 272 | 152.9 135.3–172.8ROR 156.5 · χ² 37,624 / p <1e-300 | 139.4 EB05 126.0 · IC025 +6.6 3/3 methods agree | Labeled (related wording) related wording | serious n=273 · 95% clinician | not reported in cached trials |
| Skin hypertrophy | 185 | 125.9 108.6–146.0ROR 127.9 · χ² 21,279 / p <1e-300 | 116.2 EB05 102.8 · IC025 +6.2 3/3 methods agree | Not in label — unassessed | serious n=183 | not reported in cached trials |
| Nephrogenic fibrosing dermopathy | 13 | 122.1 69.6–214.1ROR 122.2 · χ² 1,349 / p 2e-295 | 98.2 EB05 61.0 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Intensive care unit acquired weakness | 24 | 119.4 79.0–180.5ROR 119.6 · χ² 2,529 / p <1e-300 | 102.9 EB05 72.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=24 | not reported in cached trials |
| Endometrial disorder | 24 | 112.1 74.2–169.3ROR 112.3 · χ² 2,380 / p <1e-300 | 97.5 EB05 68.9 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=24 | NCT00093015: 1/2,004 (0.0%) on Epoetin Alfa (serious AE) |
| Microtia | 17 | 100.2 61.5–163.3ROR 100.3 · χ² 1,487 / p <1e-300 | 86.0 EB05 56.8 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=17 | not reported in cached trials |
| Reticulocyte count decreased | 23 | 99.0 65.1–150.6ROR 99.2 · χ² 2,020 / p <1e-300 | 87.2 EB05 61.2 · IC025 +4.3 3/3 methods agree | Lab value / disease marker | serious n=19 · 100% clinician | not reported in cached trials |
| Arteriovenous fistula thrombosis | 18 | 97.0 60.3–155.8ROR 97.1 · χ² 1,530 / p <1e-300 | 84.0 EB05 56.2 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=18 | NCT02876835: 9/1,933 (0.5%) on Epoetin Alfa (serious AE) |
| Arteriovenous fistula site complication | 31 | 96.2 67.0–138.0ROR 96.4 · χ² 2,679 / p <1e-300 | 86.5 EB05 63.9 · IC025 +4.6 3/3 methods agree | Reporting / coding artifact | serious n=31 · ♀ 77% (drug 49%) · 100% clinician | NCT00093015: 1/2,004 (0.0%) on Epoetin Alfa (serious AE) |
| Refractory cytopenia with unilineage dysplasia | 10 | 93.4 49.5–176.4ROR 93.5 · χ² 782 / p 2e-172 | 76.3 EB05 44.3 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=10 | not reported in cached trials |
| Congestive hepatopathy | 21 | 88.2 56.9–136.7ROR 88.4 · χ² 1,642 / p <1e-300 | 78.3 EB05 54.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=21 | not reported in cached trials |
| Fibrosis | 136 | 82.4 69.4–97.7ROR 83.3 · χ² 10,364 / p <1e-300 | 77.9 EB05 67.5 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=135 | NCT00093015: 1/2,019 (0.0%) control (serious AE) |
| Congenital diaphragmatic hernia | 16 | 75.3 45.7–124.2ROR 75.4 · χ² 1,055 / p 1e-231 | 66.8 EB05 43.6 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=16 | not reported in cached trials |
| Shunt occlusion | 20 | 73.2 46.8–114.4ROR 73.3 · χ² 1,298 / p 1e-284 | 66.0 EB05 45.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | not reported in cached trials |
| Enterococcus test positive | 25 | 70.9 47.6–105.7ROR 71.1 · χ² 1,590 / p <1e-300 | 65.0 EB05 46.3 · IC025 +4.2 3/3 methods agree | Lab value / disease marker | serious n=25 | not reported in cached trials |
| Hyperparathyroidism secondary | 97 | 70.9 57.9–86.8ROR 71.5 · χ² 6,360 / p <1e-300 | 67.3 EB05 56.8 · IC025 +5.3 3/3 methods agree | Not in label — unassessed | serious n=96 | NCT00093015: 1/2,004 (0.0%) on Epoetin Alfa (serious AE) |
| Intercepted product administration error | 283 | 67.7 60.2–76.2ROR 69.4 · χ² 17,860 / p <1e-300 | 65.0 EB05 58.9 · IC025 +5.7 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Chronic kidney disease-mineral and bone disorder | 36 | 61.6 44.2–85.9ROR 61.8 · χ² 2,016 / p <1e-300 | 57.8 EB05 43.6 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=36 | not reported in cached trials |
| Pseudomonal bacteraemia | 28 | 61.5 42.2–89.6ROR 61.6 · χ² 1,551 / p <1e-300 | 57.2 EB05 41.5 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=28 | not reported in cached trials |
| Skin tightness | 154 | 60.4 51.5–70.9ROR 61.2 · χ² 8,648 / p <1e-300 | 58.1 EB05 50.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=152 | not reported in cached trials |
| Bone debridement | 16 | 60.3 36.6–99.2ROR 60.4 · χ² 846 / p 3e-186 | 54.7 EB05 35.7 · IC025 +3.6 3/3 methods agree | Not in label — unassessed | serious n=15 | not reported in cached trials |
| Serum ferritin abnormal | 10 | 58.3 31.1–109.5ROR 58.4 · χ² 491 / p 4e-109 | 51.3 EB05 29.8 · IC025 +2.9 3/3 methods agree | Lab value / disease marker | serious n=9 | not reported in cached trials |
| Nephrogenic anaemia | 141 | 55.4 46.9–65.4ROR 56.0 · χ² 7,245 / p <1e-300 | 53.3 EB05 46.3 · IC025 +5.2 3/3 methods agree | Not in label — unassessed | serious n=141 | NCT00093015: 2/2,004 (0.1%) on Epoetin Alfa; 1/2,019 (0.0%) control (serious AE) |
| Peritoneal dialysis | 25 | 55.1 37.0–82.0ROR 55.2 · χ² 1,235 / p 7e-271 | 51.5 EB05 36.7 · IC025 +4.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=25 | NCT02876835: 2/1,933 (0.1%) on Epoetin Alfa (serious AE) |
| Marrow hyperplasia | 20 | 53.3 34.2–83.1ROR 53.4 · χ² 946 / p 5e-208 | 49.5 EB05 33.8 · IC025 +3.8 3/3 methods agree | Not in label — unassessed | serious n=20 | not reported in cached trials |
| Bone marrow depression | 27 | 50.0 34.1–73.3ROR 50.1 · χ² 1,214 / p 3e-266 | 47.1 EB05 34.0 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=27 · 100% clinician | not reported in cached trials |
| Wound debridement | 11 | 47.7 26.2–86.8ROR 47.7 · χ² 445 / p 4e-99 | 43.2 EB05 25.8 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious n=11 | not reported in cached trials |
| Arteriovenous fistula | 12 | 44.5 25.1–78.8ROR 44.5 · χ² 456 / p 2e-101 | 40.8 EB05 24.9 · IC025 +3.0 3/3 methods agree | Not in label — unassessed | serious n=11 | NCT00093015: 2/2,004 (0.1%) on Epoetin Alfa; 1/2,019 (0.0%) control (serious AE) |
Trial evidence (ClinicalTrials.gov)
✓ Trial adverse-event data found on ClinicalTrials.gov
Largest completed trials with posted results that list Epoetin 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 (9 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 |
|---|---|---|---|---|---|---|
| Product storage error | 1,124 | 23.4 22.1–24.8ROR 25.8 · χ² 23,886 / p <1e-300 | 23.1 EB05 22.0 · IC025 +4.4 3/3 methods agree | Reporting / coding artifact | serious PRR 2.6 | not reported in cached trials |
| Anaemia (low red blood cells) | 768 | 7.2 6.7–7.7ROR 7.6 · χ² 4,107 / p <1e-300 | 7.1 EB05 6.7 · IC025 +2.7 3/3 methods agree | Labeled — boxed warning exact term | serious PRR 5.9 | NCT00093015: 65/2,004 (3.2%) on Epoetin Alfa; 155/2,019 (7.7%) control (serious AE) |
| Dyspnoea (shortness of breath) | 632 | 2.0 1.8–2.1ROR 2.0 · χ² 319 / p 1e-71 | 2.0 EB05 1.9 · IC025 +0.9 | Not in label — unassessed | serious PRR 2.0 | NCT00093015: 10/2,004 (0.5%) on Epoetin Alfa; 10/2,019 (0.5%) control (serious AE) |
| Haemoglobin decreased | 604 | 10.5 9.7–11.4ROR 11.0 · χ² 5,181 / p <1e-300 | 10.4 EB05 9.7 · IC025 +3.2 3/3 methods agree | Labeled — boxed warning synonym match | serious PRR 7.7 | NCT00093015: 1/2,004 (0.0%) on Epoetin Alfa (serious AE) |
| Nausea | 599 | 1.4 1.3–1.5ROR 1.4 · χ² 57 / p 3e-14 | 1.4 EB05 1.3 · IC025 +0.3 | Labeled adverse reaction exact term | serious PRR 1.7 | NCT00093015: 3/2,004 (0.1%) on Epoetin Alfa; 4/2,019 (0.2%) control (serious AE) |
| Pain | 559 | 1.6 1.5–1.8ROR 1.6 · χ² 135 / p 1e-31 | 1.6 EB05 1.5 · IC025 +0.6 | Labeled adverse reaction exact term | serious PRR 2.0 | NCT00093015: 14/2,004 (0.7%) on Epoetin Alfa; 16/2,019 (0.8%) control (serious AE) |
| Diarrhoea (diarrhea) | 548 | 1.5 1.4–1.6ROR 1.5 · χ² 99 / p 1e-23 | 1.5 EB05 1.4 · IC025 +0.5 | Not in label — unassessed | serious PRR 1.9 | NCT00093015: 11/2,004 (0.5%) on Epoetin Alfa; 7/2,019 (0.3%) control (serious AE) |
| Circumstance or information capable of leading to medication error | 542 | 29.2 26.9–31.8ROR 30.6 · χ² 14,528 / p <1e-300 | 28.7 EB05 26.8 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | – | not reported in cached trials |
| Vomiting | 534 | 2.0 1.9–2.2ROR 2.1 · χ² 284 / p 6e-64 | 2.0 EB05 1.9 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 2.1 | NCT00093015: 7/2,004 (0.3%) on Epoetin Alfa; 8/2,019 (0.4%) control (serious AE) |
| Nephrogenic systemic fibrosis | 530 | 373.6 340.8–409.6ROR 391.2 · χ² 162,125 / p <1e-300 | 304.9 EB05 283.7 · IC025 +7.8 3/3 methods agree | Not in label — unassessed | serious n=528 | not reported in cached trials |
| Death | 524 | 1.1 1.0–1.2ROR 1.1 · χ² 3 / p 0.032 | 1.1 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction boxed warning mentions mortality | serious PRR 0.9 | NCT00093015: 1/2,019 (0.0%) control (serious AE) |
| Off label use (used outside approved label) | 514 | 1.1 1.0–1.1ROR 1.1 · χ² 1 / p 0.114 | 1.1 EB05 1.0 · IC025 -0.1 PRR-only: not supported by EBGM or IC | Reporting / coding artifact | serious PRR 1.0 | not reported in cached trials |
| Asthenia (weakness) | 491 | 2.3 2.1–2.5ROR 2.4 · χ² 376 / p 4e-84 | 2.3 EB05 2.2 · IC025 +1.1 3/3 methods agree | Not in label — unassessed | serious PRR 2.4 | NCT00093015: 9/2,004 (0.4%) on Epoetin Alfa; 9/2,019 (0.4%) control (serious AE) |
| Therapeutic response decreased | 458 | 13.6 12.4–14.9ROR 14.1 · χ² 5,317 / p <1e-300 | 13.5 EB05 12.5 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 18.1 · 90% clinician | not reported in cached trials |
| Hypotension (low blood pressure) | 457 | 4.1 3.7–4.5ROR 4.2 · χ² 1,063 / p 2e-233 | 4.0 EB05 3.7 · IC025 +1.9 3/3 methods agree | Not in label — unassessed | serious PRR 3.6 | NCT00093015: 16/2,004 (0.8%) on Epoetin Alfa; 13/2,019 (0.6%) control (serious AE) |
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.
- Peau d'orange — n=26, PRR 691.8 (also seen in trial arm)
- Skin fibrosis — n=102, PRR 478.9
- Nephrogenic systemic fibrosis — n=530, PRR 373.6
- Shunt stenosis — n=31, PRR 221.3
- Skin induration — n=204, PRR 195.3
- Extremity contracture — n=61, PRR 187.3
- Joint contracture — n=98, PRR 178.9
- Skin hypertrophy — n=185, PRR 125.9
- Intensive care unit acquired weakness — n=24, PRR 119.4
- Endometrial disorder — n=24, PRR 112.1 (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 Epoetin Alfa?
In FDA FAERS, the most frequently co-reported reaction terms for Epoetin Alfa are anaemia, dyspnoea, haemoglobin decreased, nausea, pain, 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 Epoetin 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 with ch.
Do FAERS signals prove that Epoetin 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 1f2d0b28-9cc5-4523-80b8-637fdaf3f7a5, effective 20260623; matched on
openfda.generic_name.exact:"EPOETIN 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, 1,094 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
EPOETIN ALFA, results-bearing studies sorted by enrollment)
Page generated 2026-10-08. 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.