Drug · FAERS side-effect profile with label screen
Amphotericin B Liposome side effects: what 2,363 FDA adverse event reports show
Drug class
Lipid-based Polyene Antifungal, Polyene Antifungal
FDA label (Established Pharmacologic Class)
Who reports
2,363 reports · 99% serious · 1,282 with death outcome · 37% female
openFDA FAERS counts, all years, deduplication not applied
Used for
Amphotericin B liposome for injection is indicated for the following: • Empirical therapy for presumed fungal infection in febrile, neutropenic patients. • Treatment of Cryptococcal Meningitis in HIV-infected patients (see DESCRIPTION OF CLINICAL STUDIES ).
FDA label, Indications and Usage
What it is
DESCRIPTION Amphotericin B liposome for injection is a sterile, non-pyrogenic, yellow lyophilized product for intravenous infusion.
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 39 strongest signals
Labeled adverse reaction 3Labeled (related wording) 10Likely indication confounding 3Reporting / coding artifact 6Not in label — unassessed 17
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.
- 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. 26 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 |
|---|---|---|---|---|---|---|
| Multiple organ dysfunction syndrome | 74 | 23.6 18.8–29.5ROR 24.3 · χ² 1,576 / p <1e-300 | 23.4 EB05 19.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 | no trial data cached |
| Hypokalaemia (low potassium) | 84 | 16.3 13.2–20.1ROR 16.8 · χ² 1,189 / p 8e-261 | 16.2 EB05 13.4 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.6 · 79% consumer | no trial data cached |
| Nephropathy toxic | 17 | 13.6 8.4–21.8ROR 13.7 · χ² 185 / p 2e-42 | 12.7 EB05 7.8 · IC025 +2.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 8.1 | no trial data cached |
| Cytomegalovirus infection | 25 | 13.4 9.0–19.7ROR 13.5 · χ² 273 / p 1e-61 | 12.8 EB05 8.8 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 7.9 | no trial data cached |
| Hypomagnesaemia | 20 | 12.8 8.3–19.8ROR 12.9 · χ² 206 / p 5e-47 | 12.0 EB05 7.7 · IC025 +2.6 3/3 methods agree | Not in label — unassessed | serious PRR 7.3 | no trial data cached |
| Candida infection (yeast infection) | 24 | 12.8 8.6–19.0ROR 12.9 · χ² 249 / p 2e-56 | 12.2 EB05 8.2 · IC025 +2.7 3/3 methods agree | Likely indication confounding term in indications | serious PRR 10.7 | no trial data cached |
| Fungal infection | 45 | 12.0 9.0–16.0ROR 12.2 · χ² 443 / p 1e-98 | 11.7 EB05 8.9 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 12.8 | no trial data cached |
| Drug resistance | 33 | 11.4 8.1–16.0ROR 11.6 · χ² 303 / p 3e-68 | 10.9 EB05 7.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 | no trial data cached |
| Toxic epidermal necrolysis (severe skin peeling reaction) | 19 | 11.2 7.1–17.5ROR 11.3 · χ² 166 / p 2e-38 | 10.2 EB05 6.5 · IC025 +2.4 3/3 methods agree | Not in label — unassessed | serious PRR 6.5 | no trial data cached |
| Septic shock | 52 | 10.7 8.2–14.0ROR 10.9 · χ² 447 / p 1e-99 | 10.3 EB05 8.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Bone marrow failure | 24 | 10.4 7.0–15.5ROR 10.5 · χ² 195 / p 1e-44 | 9.6 EB05 6.5 · IC025 +2.4 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.1 · 77% consumer | no trial data cached |
| Renal tubular necrosis | 11 | 9.9 5.5–17.9ROR 10.0 · χ² 80 / p 2e-19 | 8.0 EB05 4.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.8 | no trial data cached |
| Pancytopenia (all blood cells low) | 60 | 9.6 7.4–12.3ROR 9.8 · χ² 452 / p 1e-100 | 9.2 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 · 72% consumer | no trial data cached |
| Electrolyte imbalance | 12 | 9.3 5.3–16.3ROR 9.3 · χ² 80 / p 2e-19 | 7.6 EB05 4.4 · IC025 +1.8 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 | no trial data cached |
| Blood potassium decreased | 29 | 8.6 6.0–12.3ROR 8.7 · χ² 186 / p 1e-42 | 7.8 EB05 5.6 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 · 93% consumer | no trial data cached |
| Hallucination, visual | 20 | 8.5 5.5–13.1ROR 8.5 · χ² 124 / p 4e-29 | 7.4 EB05 5.0 · IC025 +2.1 3/3 methods agree | Not in label — unassessed | serious PRR 5.6 · ♀ 75% (drug 37%) | no trial data cached |
| Treatment failure | 75 | 8.1 6.5–10.1ROR 8.3 · χ² 462 / p 8e-103 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 | no trial data cached |
| Acute myeloid leukaemia | 13 | 7.4 4.3–12.8ROR 7.4 · χ² 66 / p 2e-16 | 6.1 EB05 3.7 · IC025 +1.6 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Tachypnoea | 11 | 7.2 4.0–13.0ROR 7.2 · χ² 53 / p 2e-13 | 5.8 EB05 3.4 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 4.3 | no trial data cached |
| Drug ineffective (drug did not work) | 1,048 | 7.1 6.8–7.4ROR 11.9 · χ² 5,814 / p <1e-300 | 7.0 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 11.6 · 85% consumer | no trial data cached |
| Liver function test abnormal | 23 | 7.0 4.6–10.5ROR 7.0 · χ² 112 / p 2e-26 | 6.2 EB05 4.3 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 5.1 · ♀ 65% (drug 37%) · 91% consumer | no trial data cached |
| Blood creatinine increased | 47 | 6.4 4.8–8.5ROR 6.5 · χ² 208 / p 2e-47 | 6.0 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 · 74% consumer | no trial data cached |
| Renal impairment | 58 | 6.2 4.8–7.9ROR 6.3 · χ² 246 / p 9e-56 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.7 | no trial data cached |
| Drug ineffective for unapproved indication | 38 | 6.1 4.4–8.3ROR 6.1 · χ² 156 / p 5e-36 | 5.7 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.9 | no trial data cached |
| Fluid overload | 10 | 6.0 3.2–11.2ROR 6.0 · χ² 37 / p 6e-10 | 4.8 EB05 2.8 · IC025 +1.2 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.5 | no trial data cached |
| Pancreatitis acute | 15 | 6.0 3.6–9.9ROR 6.0 · χ² 57 / p 2e-14 | 5.1 EB05 3.3 · IC025 +1.5 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Respiratory failure | 47 | 5.7 4.3–7.6ROR 5.8 · χ² 179 / p 4e-41 | 5.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 96 | 5.6 4.6–6.8ROR 5.8 · χ² 360 / p 1e-80 | 5.5 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | no trial data cached |
| Transaminases increased | 14 | 5.6 3.3–9.4ROR 5.6 · χ² 48 / p 2e-12 | 4.8 EB05 3.0 · IC025 +1.4 3/3 methods agree | Not in label — unassessed | serious PRR 3.5 | no trial data cached |
| Acute respiratory distress syndrome | 11 | 5.5 3.1–10.0ROR 5.5 · χ² 36 / p 8e-10 | 4.6 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 3.2 | no trial data cached |
| Febrile neutropenia | 40 | 5.4 3.9–7.3ROR 5.4 · χ² 138 / p 4e-32 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 | no trial data cached |
| Incorrect route of product administration | 10 | 5.3 2.8–9.8ROR 5.3 · χ² 31 / p 2e-8 | 4.3 EB05 2.5 · IC025 +1.1 3/3 methods agree | Reporting / coding artifact | serious PRR 6.1 | no trial data cached |
| Drug eruption | 10 | 5.0 2.7–9.4ROR 5.1 · χ² 28 / p 5e-8 | 4.2 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 3.4 | no trial data cached |
| Hepatic function abnormal | 21 | 5.0 3.3–7.7ROR 5.1 · χ² 64 / p 7e-16 | 4.6 EB05 3.2 · IC025 +1.5 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.2 · 71% consumer | no trial data cached |
| Respiratory distress | 15 | 4.8 2.9–8.0ROR 4.8 · χ² 42 / p 5e-11 | 4.2 EB05 2.7 · IC025 +1.2 3/3 methods agree | Not in label — unassessed | serious PRR 2.8 | no trial data cached |
| Shock | 12 | 4.7 2.7–8.2ROR 4.7 · χ² 31 / p 1e-8 | 4.0 EB05 2.5 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.7 | no trial data cached |
| Hepatic failure | 15 | 4.4 2.7–7.3ROR 4.4 · χ² 36 / p 9e-10 | 3.9 EB05 2.5 · IC025 +1.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.6 | no trial data cached |
| Myelosuppression | 15 | 3.9 2.4–6.5ROR 3.9 · χ² 30 / p 2e-8 | 3.5 EB05 2.3 · IC025 +1.0 3/3 methods agree | Not in label — unassessed | serious PRR 2.3 | no trial data cached |
| Mucosal inflammation | 11 | 3.7 2.1–6.8ROR 3.8 · χ² 20 / p 5e-6 | 3.3 EB05 2.0 · IC025 +0.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.3 | 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 |
|---|---|---|---|---|---|---|
| Drug ineffective (drug did not work) | 1,048 | 7.1 6.8–7.4ROR 11.9 · χ² 5,814 / p <1e-300 | 7.0 EB05 6.7 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 11.6 · 85% consumer | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 96 | 5.6 4.6–6.8ROR 5.8 · χ² 360 / p 1e-80 | 5.5 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.3 | no trial data cached |
| Hypokalaemia (low potassium) | 84 | 16.3 13.2–20.1ROR 16.8 · χ² 1,189 / p 8e-261 | 16.2 EB05 13.4 · IC025 +3.5 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 9.6 · 79% consumer | no trial data cached |
| Treatment failure | 75 | 8.1 6.5–10.1ROR 8.3 · χ² 462 / p 8e-103 | 7.8 EB05 6.4 · IC025 +2.6 3/3 methods agree | Reporting / coding artifact | serious PRR 9.1 | no trial data cached |
| Multiple organ dysfunction syndrome | 74 | 23.6 18.8–29.5ROR 24.3 · χ² 1,576 / p <1e-300 | 23.4 EB05 19.3 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious PRR 13.7 | no trial data cached |
| Pancytopenia (all blood cells low) | 60 | 9.6 7.4–12.3ROR 9.8 · χ² 452 / p 1e-100 | 9.2 EB05 7.3 · IC025 +2.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 5.6 · 72% consumer | no trial data cached |
| Renal impairment | 58 | 6.2 4.8–7.9ROR 6.3 · χ² 246 / p 9e-56 | 5.9 EB05 4.7 · IC025 +2.1 3/3 methods agree | Likely indication confounding term in indications | serious PRR 3.7 | no trial data cached |
| Septic shock | 52 | 10.7 8.2–14.0ROR 10.9 · χ² 447 / p 1e-99 | 10.3 EB05 8.1 · IC025 +2.8 3/3 methods agree | Not in label — unassessed | serious PRR 6.2 | no trial data cached |
| Respiratory failure | 47 | 5.7 4.3–7.6ROR 5.8 · χ² 179 / p 4e-41 | 5.4 EB05 4.2 · IC025 +2.0 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 3.3 | no trial data cached |
| Blood creatinine increased | 47 | 6.4 4.8–8.5ROR 6.5 · χ² 208 / p 2e-47 | 6.0 EB05 4.7 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 4.2 · 74% consumer | no trial data cached |
| Fungal infection | 45 | 12.0 9.0–16.0ROR 12.2 · χ² 443 / p 1e-98 | 11.7 EB05 8.9 · IC025 +2.9 3/3 methods agree | Likely indication confounding term in indications | serious PRR 12.8 | no trial data cached |
| Febrile neutropenia | 40 | 5.4 3.9–7.3ROR 5.4 · χ² 138 / p 4e-32 | 5.1 EB05 3.9 · IC025 +1.8 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 | no trial data cached |
| Drug ineffective for unapproved indication | 38 | 6.1 4.4–8.3ROR 6.1 · χ² 156 / p 5e-36 | 5.7 EB05 4.3 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 7.9 | no trial data cached |
| Drug resistance | 33 | 11.4 8.1–16.0ROR 11.6 · χ² 303 / p 3e-68 | 10.9 EB05 7.9 · IC025 +2.7 3/3 methods agree | Reporting / coding artifact | serious PRR 7.5 | no trial data cached |
| Blood potassium decreased | 29 | 8.6 6.0–12.3ROR 8.7 · χ² 186 / p 1e-42 | 7.8 EB05 5.6 · IC025 +2.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.0 · 93% consumer | 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.
- Multiple organ dysfunction syndrome — n=74, PRR 23.6
- Cytomegalovirus infection — n=25, PRR 13.4
- Hypomagnesaemia — n=20, PRR 12.8
- Septic shock — n=52, PRR 10.7
- Hallucination, visual — n=20, PRR 8.5
✓ A hand-written Bradford Hill causality assessment exists for this drug: Amphotericin B ↔ Hypokalaemia / electrolyte wasting.
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 Amphotericin B Liposome?
In FDA FAERS, the most frequently co-reported reaction terms for Amphotericin B Liposome are acute kidney injury, hypokalaemia, multiple organ dysfunction syndrome, pancytopenia, renal impairment, septic shock. 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 Amphotericin B Liposome have an FDA boxed warning?
No. The FDA label retrieved for Amphotericin B Liposome has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Amphotericin B Liposome 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 a96a734f-d1c4-4d42-93c2-7c336da7f7b9, effective 20250606; matched on
openfda.generic_name.exact:"AMPHOTERICIN B LIPOSOME") - 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, 65 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.