Drug · FAERS side-effect profile with label screen
Albumin Human side effects: what 4,765 FDA adverse event reports show
Drug class
Not stated in label
Brand names
Albuminex
openFDA label
Who reports
4,765 reports · 96% serious · 1,460 with death outcome · 45% female
openFDA FAERS counts, all years, deduplication not applied
Used for
ALBUMINEX 25% is a 25% albumin solution indicated for adults and children : Hypovolemia ( 1.1 ) Ascites ( 1.2 ) Hypoalbuminemia including from burns ( 1.3 ) Acute Nephrosis ( 1.4 ) Acute Respiratory Distress Syndrome (ARDS) ( 1.5 ) Cardiopulmonary Bypa.
FDA label, Indications and Usage
What it is
ALBUMINEX 25% is a sterile, ready-for-use, clear, slightly viscous, almost colorless, yellow, amber or slightly green aqueous solution of human albumin for single dose intravenous infusion. It is prepared from the pooled plasma of US donors in FDA-licensed facilities in the US.
FDA label, Description section
Boxed warning
None in the current label
How to read this page. FAERS is a spontaneous-reporting system: counts are not incidence rates and a signal is not proof of causation.
Each reaction below is run through an automated screen — is the term in the FDA label (known), in the indications (the disease being treated), an administrative/coding term, or none of these (unlabeled)?
That screen is mechanical text matching, not a causality assessment. The 30 hand-written Bradford Hill assessments are on the causality assessment page. Not medical advice.
Causality screen of the 40 strongest signals
Labeled adverse reaction 2Labeled (related wording) 4Likely indication confounding 6Reporting / coding artifact 1Lab value / disease marker 3Not in label — unassessed 24
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 flags pairs whose reports are unusually skewed by sex or come mostly from consumers rather than clinicians. 258 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.
Show:
| Reaction | Reports | PRR 95% CI · ROR · χ²/p | EBGM EB05 · IC025 | Label screen | Serious-only & strata | Trial cross-check |
|---|---|---|---|---|---|---|
| Multi-organ failure | 173 | 43.8 37.8–50.7ROR 45.4 · χ² 7,126 / p <1e-300 | 43.2 EB05 38.0 · IC025 +5.0 3/3 methods agree | Not in label — unassessed | serious PRR 25.9 | no trial data cached |
| Fear | 219 | 35.8 31.5–40.8ROR 37.5 · χ² 7,328 / p <1e-300 | 35.4 EB05 31.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 28.9 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 107 | 31.4 26.0–37.9ROR 32.1 · χ² 3,101 / p <1e-300 | 31.1 EB05 26.4 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious PRR 18.8 · ♀ 75% (drug 45%) · 97% clinician | no trial data cached |
| Renal injury | 197 | 29.1 25.3–33.3ROR 30.3 · χ² 5,280 / p <1e-300 | 28.8 EB05 25.6 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 17.4 | no trial data cached |
| Anhedonia | 156 | 26.1 22.3–30.4ROR 26.9 · χ² 3,716 / p <1e-300 | 25.8 EB05 22.6 · IC025 +4.3 3/3 methods agree | Not in label — unassessed | serious PRR 17.1 | no trial data cached |
| Tachypnoea | 68 | 22.2 17.5–28.1ROR 22.5 · χ² 1,349 / p 2e-295 | 22.0 EB05 17.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious PRR 13.4 | no trial data cached |
| Disseminated intravascular coagulation | 69 | 21.6 17.1–27.3ROR 21.9 · χ² 1,329 / p 3e-291 | 21.4 EB05 17.5 · IC025 +3.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 12.9 | no trial data cached |
| Generalised oedema | 57 | 20.5 15.8–26.5ROR 20.7 · χ² 1,031 / p 2e-226 | 20.2 EB05 16.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 13.6 · 91% clinician | no trial data cached |
| Ascites | 132 | 19.8 16.7–23.5ROR 20.4 · χ² 2,333 / p <1e-300 | 19.7 EB05 17.0 · IC025 +3.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 12.0 | no trial data cached |
| Cytokine release syndrome | 73 | 16.9 13.5–21.2ROR 17.2 · χ² 1,074 / p 8e-236 | 16.8 EB05 13.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 10.0 · 93% clinician | no trial data cached |
| Injury | 270 | 16.9 15.0–18.9ROR 17.8 · χ² 4,013 / p <1e-300 | 16.8 EB05 15.2 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 12.5 | no trial data cached |
| Stevens-johnson syndrome (severe blistering skin reaction) | 78 | 15.4 12.4–19.3ROR 15.7 · χ² 1,037 / p 8e-228 | 15.3 EB05 12.6 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 9.3 · 97% clinician | no trial data cached |
| Acute respiratory failure | 64 | 14.7 11.6–18.8ROR 14.9 · χ² 805 / p 3e-177 | 14.6 EB05 11.8 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious PRR 8.9 · ♀ 22% (drug 45%) | no trial data cached |
| Multiple organ dysfunction syndrome | 93 | 14.7 12.0–18.0ROR 15.0 · χ² 1,172 / p 4e-257 | 14.6 EB05 12.2 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · 95% clinician | no trial data cached |
| Unevaluable event | 248 | 14.5 12.8–16.3ROR 15.2 · χ² 3,095 / p <1e-300 | 14.4 EB05 12.9 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 15.2 | no trial data cached |
| Septic shock | 141 | 14.4 12.2–16.9ROR 14.8 · χ² 1,742 / p <1e-300 | 14.3 EB05 12.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.6 · 93% clinician | no trial data cached |
| Hypoxia (low oxygen) | 108 | 13.6 11.3–16.4ROR 13.9 · χ² 1,245 / p 6e-273 | 13.5 EB05 11.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.3 | no trial data cached |
| Hypokalaemia (low potassium) | 138 | 13.3 11.2–15.6ROR 13.6 · χ² 1,551 / p <1e-300 | 13.2 EB05 11.4 · IC025 +3.4 3/3 methods agree | Not in label — unassessed | serious PRR 8.1 · 96% clinician | no trial data cached |
| Renal impairment | 251 | 13.2 11.7–14.9ROR 13.9 · χ² 2,829 / p <1e-300 | 13.2 EB05 11.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Renal failure acute | 129 | 13.2 11.1–15.7ROR 13.6 · χ² 1,444 / p <1e-300 | 13.1 EB05 11.3 · IC025 +3.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.0 | no trial data cached |
| Renal failure (kidney failure) | 391 | 12.9 11.7–14.2ROR 14.0 · χ² 4,292 / p <1e-300 | 12.8 EB05 11.8 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 | no trial data cached |
| Blood urea increased | 49 | 12.8 9.7–17.0ROR 13.0 · χ² 522 / p 8e-116 | 12.6 EB05 9.7 · IC025 +3.0 3/3 methods agree | Lab value / disease marker | serious PRR 8.3 · 95% clinician | no trial data cached |
| Eye inflammation | 27 | 12.6 8.7–18.4ROR 12.7 · χ² 277 / p 2e-62 | 12.1 EB05 8.4 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious n=27 · ♀ 100% (drug 45%) · 96% clinician | no trial data cached |
| Covid-19 pneumonia | 33 | 12.2 8.7–17.2ROR 12.3 · χ² 329 / p 9e-74 | 11.8 EB05 8.5 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · ♀ 19% (drug 45%) | no trial data cached |
| Brain oedema | 35 | 12.2 8.8–17.0ROR 12.3 · χ² 349 / p 4e-78 | 11.8 EB05 8.6 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 | no trial data cached |
| Shock | 63 | 12.2 9.5–15.6ROR 12.3 · χ² 634 / p 3e-140 | 11.9 EB05 9.6 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications; also in warnings | serious PRR 7.3 · 91% clinician | no trial data cached |
| Clostridium difficile colitis | 29 | 12.0 8.4–17.3ROR 12.1 · χ² 282 / p 1e-63 | 11.5 EB05 8.1 · IC025 +2.7 3/3 methods agree | Not in label — unassessed | serious PRR 7.4 · 96% clinician | no trial data cached |
| Blood bilirubin increased | 73 | 11.9 9.5–14.9ROR 12.1 · χ² 716 / p 5e-158 | 11.7 EB05 9.5 · IC025 +3.1 3/3 methods agree | Lab value / disease marker | serious PRR 8.1 | no trial data cached |
| Bacteraemia | 31 | 11.6 8.2–16.5ROR 11.7 · χ² 290 / p 3e-65 | 11.1 EB05 7.9 · IC025 +2.7 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 7.0 | no trial data cached |
| Hypocalcaemia (low calcium) | 49 | 11.4 8.7–15.1ROR 11.6 · χ² 456 / p 2e-101 | 11.1 EB05 8.6 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 · 94% clinician | no trial data cached |
| Hepatic encephalopathy | 24 | 11.3 7.6–16.9ROR 11.4 · χ² 215 / p 5e-49 | 10.5 EB05 7.1 · IC025 +2.5 3/3 methods agree | Not in label — unassessed | serious PRR 6.8 · 95% clinician | no trial data cached |
| Lymphocyte count decreased | 45 | 11.2 8.4–15.0ROR 11.3 · χ² 408 / p 5e-91 | 10.8 EB05 8.3 · IC025 +2.8 3/3 methods agree | Lab value / disease marker | serious PRR 8.1 · 98% clinician | no trial data cached |
| Pulmonary oedema | 112 | 11.0 9.2–13.2ROR 11.3 · χ² 1,009 / p 8e-222 | 10.9 EB05 9.2 · IC025 +3.1 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.7 | no trial data cached |
| Respiratory failure | 182 | 11.0 9.5–12.7ROR 11.4 · χ² 1,645 / p <1e-300 | 10.9 EB05 9.6 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 · 90% clinician | no trial data cached |
| Encephalopathy | 61 | 11.0 8.6–14.1ROR 11.1 · χ² 543 / p 3e-120 | 10.7 EB05 8.5 · IC025 +2.9 3/3 methods agree | Not in label — unassessed | serious PRR 6.6 | no trial data cached |
| Coagulopathy | 41 | 10.9 8.0–14.8ROR 11.0 · χ² 357 / p 5e-80 | 10.4 EB05 7.8 · IC025 +2.8 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 6.6 | no trial data cached |
| Cytomegalovirus infection | 41 | 10.9 8.0–14.7ROR 11.0 · χ² 357 / p 7e-80 | 10.4 EB05 7.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.4 · 100% clinician | no trial data cached |
| Stress | 173 | 10.6 9.2–12.3ROR 11.0 · χ² 1,497 / p <1e-300 | 10.5 EB05 9.2 · IC025 +3.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.5 | no trial data cached |
| Pleural effusion | 146 | 10.6 9.0–12.4ROR 10.9 · χ² 1,256 / p 3e-275 | 10.4 EB05 9.1 · IC025 +3.1 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Anaphylactic shock | 61 | 10.5 8.2–13.5ROR 10.6 · χ² 514 / p 5e-114 | 10.2 EB05 8.1 · IC025 +2.9 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.3 · 90% clinician | no trial data cached |
Trial evidence (ClinicalTrials.gov)
Trial cross-check not yet run for this drug (ClinicalTrials.gov pull covers the 800 most-reported drugs first).
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 |
|---|---|---|---|---|---|---|
| Renal failure (kidney failure) | 391 | 12.9 11.7–14.2ROR 14.0 · χ² 4,292 / p <1e-300 | 12.8 EB05 11.8 · IC025 +3.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 7.7 | no trial data cached |
| Pyrexia (fever) | 328 | 4.2 3.8–4.6ROR 4.4 · χ² 800 / p 3e-176 | 4.1 EB05 3.8 · IC025 +1.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.1 | no trial data cached |
| Pain | 319 | 2.3 2.1–2.5ROR 2.4 · χ² 235 / p 2e-53 | 2.3 EB05 2.1 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.1 | no trial data cached |
| Dyspnoea (shortness of breath) | 278 | 2.2 1.9–2.4ROR 2.2 · χ² 177 / p 9e-41 | 2.2 EB05 2.0 · IC025 +0.9 | Labeled adverse reaction exact term | serious PRR 1.8 | no trial data cached |
| Pneumonia (lung infection) | 273 | 3.7 3.3–4.2ROR 3.9 · χ² 548 / p 2e-121 | 3.7 EB05 3.3 · IC025 +1.7 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 · 92% clinician | no trial data cached |
| Injury | 270 | 16.9 15.0–18.9ROR 17.8 · χ² 4,013 / p <1e-300 | 16.8 EB05 15.2 · IC025 +3.8 3/3 methods agree | Likely indication confounding term in indications | serious PRR 12.5 | no trial data cached |
| Hypotension (low blood pressure) | 264 | 5.8 5.2–6.5ROR 6.1 · χ² 1,054 / p 2e-231 | 5.7 EB05 5.2 · IC025 +2.3 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.0 | no trial data cached |
| Anxiety | 260 | 4.0 3.6–4.5ROR 4.2 · χ² 592 / p 4e-131 | 4.0 EB05 3.6 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Renal impairment | 251 | 13.2 11.7–14.9ROR 13.9 · χ² 2,829 / p <1e-300 | 13.2 EB05 11.8 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious PRR 8.2 | no trial data cached |
| Unevaluable event | 248 | 14.5 12.8–16.3ROR 15.2 · χ² 3,095 / p <1e-300 | 14.4 EB05 12.9 · IC025 +3.6 3/3 methods agree | Reporting / coding artifact | serious PRR 15.2 | no trial data cached |
| Sepsis (blood infection) | 228 | 9.0 7.9–10.2ROR 9.4 · χ² 1,619 / p <1e-300 | 8.9 EB05 8.0 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 5.4 · 91% clinician | no trial data cached |
| Death | 227 | 1.2 1.0–1.3ROR 1.2 · χ² 5 / p 0.012 | 1.2 EB05 1.0 · IC025 -0.0 PRR-only: not supported by EBGM or IC | Outcome field, not a reaction | serious PRR 0.7 | no trial data cached |
| Fear | 219 | 35.8 31.5–40.8ROR 37.5 · χ² 7,328 / p <1e-300 | 35.4 EB05 31.7 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious PRR 28.9 | no trial data cached |
| Renal injury | 197 | 29.1 25.3–33.3ROR 30.3 · χ² 5,280 / p <1e-300 | 28.8 EB05 25.6 · IC025 +4.5 3/3 methods agree | Likely indication confounding term in indications | serious PRR 17.4 | no trial data cached |
| Emotional distress | 195 | 7.1 6.2–8.1ROR 7.3 · χ² 1,014 / p 7e-223 | 7.0 EB05 6.2 · IC025 +2.6 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious PRR 4.8 | no trial data cached |
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.
- Multi-organ failure — n=173, PRR 43.8
- Fear — n=219, PRR 35.8
- Toxic epidermal necrolysis — n=107, PRR 31.4
- Anhedonia — n=156, PRR 26.1
- Tachypnoea — n=68, PRR 22.2
- Generalised oedema — n=57, PRR 20.5
- Cytokine release syndrome — n=73, PRR 16.9
- Stevens-johnson syndrome — n=78, PRR 15.4
- Acute respiratory failure — n=64, PRR 14.7
- Multiple organ dysfunction syndrome — n=93, PRR 14.7
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 Albumin Human?
In FDA FAERS, the most frequently co-reported reaction terms for Albumin Human are renal failure, pyrexia, pain, dyspnoea, pneumonia, injury. 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 Albumin Human have an FDA boxed warning?
No. The FDA label retrieved for Albumin Human has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Albumin Human 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 167f48d0-8ae5-4f7e-b050-9673dad78acc, effective 20241231; matched on
openfda.generic_name.exact:"ALBUMIN HUMAN") - 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, 298 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
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.