Drug · FAERS side-effect profile with label screen
Amphotericin B side effects: what 12,456 FDA adverse event reports show
Drug class
Lipid-based Polyene Antifungal, Polyene Antifungal
FDA label (Established Pharmacologic Class)
Who reports
12,456 reports · 95% serious · 4,439 with death outcome · 40% 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 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 40 strongest signals
Labeled (related wording) 3Likely indication confounding 5Reporting / coding artifact 1Lab value / disease marker 2Not in label — unassessed 29
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. 1,011 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 |
|---|---|---|---|---|---|---|
| Intermittent positive pressure breathing | 10 | 4,150.7 1,301.9–13,232.6ROR 4,154.0 · χ² 10,697 / p <1e-300 | 362.4 EB05 210.4 · IC025 +3.3 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Vascular anastomotic haemorrhage | 16 | 2,656.4 1,205.7–5,852.6ROR 2,659.8 · χ² 15,329 / p <1e-300 | 458.9 EB05 299.5 · IC025 +4.2 3/3 methods agree | Labeled (related wording) related wording | serious n=16 | no trial data cached |
| Vena cava injury | 23 | 587.5 365.3–944.9ROR 588.6 · χ² 9,518 / p <1e-300 | 318.9 EB05 223.8 · IC025 +4.7 3/3 methods agree | Not in label — unassessed | serious n=23 · ♀ 0% (drug 40%) | no trial data cached |
| Pyelonephritis fungal | 17 | 513.2 298.0–883.8ROR 513.9 · χ² 6,252 / p <1e-300 | 272.3 EB05 180.0 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=17 | no trial data cached |
| Protothecosis | 21 | 484.2 297.9–787.1ROR 485.1 · χ² 7,471 / p <1e-300 | 279.7 EB05 193.0 · IC025 +4.5 3/3 methods agree | Not in label — unassessed | serious n=21 | no trial data cached |
| Choroiditis | 72 | 399.8 309.3–516.8ROR 402.1 · χ² 22,763 / p <1e-300 | 297.0 EB05 243.7 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=72 · ♀ 0% (drug 40%) | no trial data cached |
| Foetal anaemia | 25 | 395.3 255.7–611.2ROR 396.1 · χ² 7,626 / p <1e-300 | 256.8 EB05 182.9 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=25 · ♀ 100% (drug 40%) | no trial data cached |
| Perineal cyst | 13 | 385.4 210.9–704.5ROR 385.8 · χ² 3,739 / p <1e-300 | 214.7 EB05 133.5 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=13 | no trial data cached |
| Hepatosplenic candidiasis | 26 | 359.7 235.5–549.5ROR 360.5 · χ² 7,352 / p <1e-300 | 243.1 EB05 174.3 · IC025 +4.8 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=26 · 100% clinician | no trial data cached |
| Diaphragmatic injury | 12 | 326.6 175.9–606.4ROR 326.9 · χ² 2,988 / p <1e-300 | 190.7 EB05 116.3 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Fungal disease carrier | 16 | 316.2 185.3–539.6ROR 316.6 · χ² 3,963 / p <1e-300 | 202.0 EB05 131.8 · IC025 +4.0 3/3 methods agree | Reporting / coding artifact | serious n=16 | no trial data cached |
| Fungal endocarditis | 46 | 313.0 228.5–428.7ROR 314.2 · χ² 11,776 / p <1e-300 | 237.6 EB05 185.3 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=45 · 100% clinician | no trial data cached |
| Disseminated mucormycosis | 58 | 296.3 224.2–391.6ROR 297.7 · χ² 14,235 / p <1e-300 | 232.4 EB05 186.4 · IC025 +5.9 3/3 methods agree | Not in label — unassessed | serious n=58 · 98% clinician | no trial data cached |
| Rhinocerebral mucormycosis | 48 | 274.8 202.6–372.8ROR 275.9 · χ² 11,001 / p <1e-300 | 215.7 EB05 169.2 · IC025 +5.6 3/3 methods agree | Not in label — unassessed | serious n=48 · ♀ 64% (drug 40%) · 100% clinician | no trial data cached |
| Disseminated coccidioidomycosis | 20 | 274.4 171.0–440.3ROR 274.9 · χ² 4,444 / p <1e-300 | 192.6 EB05 131.6 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=20 · 95% clinician | no trial data cached |
| Serratia sepsis | 15 | 267.8 155.3–461.9ROR 268.1 · χ² 3,207 / p <1e-300 | 178.6 EB05 114.9 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=15 | no trial data cached |
| Intracranial infection | 16 | 253.0 149.6–428.0ROR 253.3 · χ² 3,270 / p <1e-300 | 174.3 EB05 113.8 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Central nervous system fungal infection | 28 | 252.6 169.8–375.9ROR 253.2 · χ² 5,875 / p <1e-300 | 191.0 EB05 138.7 · IC025 +4.9 3/3 methods agree | Labeled (related wording) related wording | serious n=28 · 93% clinician | no trial data cached |
| Fusarium infection | 89 | 252.2 201.9–314.9ROR 254.0 · χ² 19,112 / p <1e-300 | 209.2 EB05 175.2 · IC025 +6.3 3/3 methods agree | Not in label — unassessed | serious n=89 · 97% clinician | no trial data cached |
| Osteomyelitis fungal | 20 | 246.0 153.8–393.3ROR 246.4 · χ² 4,039 / p <1e-300 | 178.2 EB05 121.8 · IC025 +4.4 3/3 methods agree | Not in label — unassessed | serious n=20 · 100% clinician | no trial data cached |
| Cerebral aspergillosis | 78 | 245.3 193.5–310.9ROR 246.8 · χ² 16,321 / p <1e-300 | 203.2 EB05 168.1 · IC025 +6.1 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=78 · 97% clinician | no trial data cached |
| Geotrichum infection | 27 | 245.0 163.6–366.8ROR 245.5 · χ² 5,506 / p <1e-300 | 185.7 EB05 134.0 · IC025 +4.8 3/3 methods agree | Not in label — unassessed | serious n=27 · 96% clinician | no trial data cached |
| Blood immunoglobulin m abnormal | 13 | 239.8 134.1–428.9ROR 240.1 · χ² 2,497 / p <1e-300 | 160.7 EB05 99.9 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=13 | no trial data cached |
| Renal cyst haemorrhage | 26 | 226.0 150.1–340.3ROR 226.5 · χ² 4,930 / p <1e-300 | 173.8 EB05 124.7 · IC025 +4.7 3/3 methods agree | Labeled (related wording) related wording | serious n=26 · ♀ 0% (drug 40%) | no trial data cached |
| Fluorosis | 10 | 218.5 113.0–422.3ROR 218.6 · χ² 1,725 / p <1e-300 | 141.6 EB05 82.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Scedosporium infection | 77 | 210.6 166.3–266.8ROR 211.9 · χ² 14,070 / p <1e-300 | 178.8 EB05 147.7 · IC025 +6.0 3/3 methods agree | Not in label — unassessed | serious n=77 · 96% clinician | no trial data cached |
| Pericoronitis | 10 | 210.2 108.9–405.7ROR 210.3 · χ² 1,667 / p <1e-300 | 138.1 EB05 80.2 · IC025 +3.2 3/3 methods agree | Not in label — unassessed | serious n=10 | no trial data cached |
| Pulmonary mucormycosis | 57 | 209.4 159.0–275.6ROR 210.3 · χ² 10,313 / p <1e-300 | 175.2 EB05 140.2 · IC025 +5.7 3/3 methods agree | Not in label — unassessed | serious n=57 · 100% clinician | no trial data cached |
| Trichosporon infection | 43 | 205.1 149.5–281.5ROR 205.9 · χ² 7,594 / p <1e-300 | 169.1 EB05 130.8 · IC025 +5.4 3/3 methods agree | Not in label — unassessed | serious n=43 · 100% clinician | no trial data cached |
| Disseminated blastomycosis | 18 | 201.9 123.8–329.3ROR 202.2 · χ² 3,032 / p <1e-300 | 151.5 EB05 101.4 · IC025 +4.2 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Splenic embolism | 12 | 201.2 110.6–366.3ROR 201.4 · χ² 1,958 / p <1e-300 | 140.1 EB05 85.4 · IC025 +3.5 3/3 methods agree | Not in label — unassessed | serious n=12 | no trial data cached |
| Perinephric abscess | 16 | 196.8 117.2–330.3ROR 197.0 · χ² 2,614 / p <1e-300 | 145.8 EB05 95.1 · IC025 +4.0 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Disseminated aspergillosis | 49 | 196.5 146.2–264.1ROR 197.3 · χ² 8,348 / p <1e-300 | 164.6 EB05 129.5 · IC025 +5.5 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=49 · 92% clinician | no trial data cached |
| Mucormycosis | 252 | 182.8 160.7–207.9ROR 186.5 · χ² 40,881 / p <1e-300 | 162.7 EB05 146.6 · IC025 +6.8 3/3 methods agree | Not in label — unassessed | serious n=251 · 96% clinician | no trial data cached |
| Dehiscence | 18 | 176.8 108.8–287.4ROR 177.1 · χ² 2,687 / p <1e-300 | 137.0 EB05 91.7 · IC025 +4.1 3/3 methods agree | Not in label — unassessed | serious n=18 | no trial data cached |
| Eye infection fungal | 33 | 160.7 112.4–229.6ROR 161.1 · χ² 4,630 / p <1e-300 | 135.3 EB05 100.8 · IC025 +4.9 3/3 methods agree | Likely indication confounding term in indications | serious n=33 | no trial data cached |
| Emphysematous pyelonephritis | 16 | 160.0 95.8–267.2ROR 160.2 · χ² 2,163 / p <1e-300 | 124.7 EB05 81.4 · IC025 +3.9 3/3 methods agree | Not in label — unassessed | serious n=16 | no trial data cached |
| Abscess fungal | 14 | 157.1 90.8–271.6ROR 157.2 · χ² 1,843 / p <1e-300 | 120.4 EB05 76.2 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious n=14 | no trial data cached |
| Cryptococcal meningoencephalitis | 11 | 154.8 83.5–287.0ROR 154.9 · χ² 1,400 / p <1e-300 | 114.2 EB05 68.0 · IC025 +3.3 3/3 methods agree | Likely indication confounding shares a disease stem with the indications wording | serious n=11 | no trial data cached |
| Blood immunoglobulin g abnormal | 13 | 145.8 82.7–257.0ROR 146.0 · χ² 1,588 / p <1e-300 | 112.4 EB05 69.9 · IC025 +3.6 3/3 methods agree | Lab value / disease marker | serious n=13 | 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) | 3,082 | 3.9 3.8–4.1ROR 4.9 · χ² 7,218 / p <1e-300 | 3.9 EB05 3.8 · IC025 +1.9 3/3 methods agree | Reporting / coding artifact | serious PRR 6.6 · 96% clinician | no trial data cached |
| Off label use (used outside approved label) | 1,391 | 2.7 2.6–2.8ROR 2.9 · χ² 1,550 / p <1e-300 | 2.7 EB05 2.6 · IC025 +1.3 3/3 methods agree | Reporting / coding artifact | serious PRR 2.8 · 94% clinician | no trial data cached |
| Condition aggravated | 774 | 4.3 4.0–4.6ROR 4.5 · χ² 1,998 / p <1e-300 | 4.3 EB05 4.1 · IC025 +2.0 3/3 methods agree | Reporting / coding artifact | serious PRR 3.9 · 94% clinician | no trial data cached |
| Pyrexia (fever) | 713 | 3.5 3.2–3.7ROR 3.6 · χ² 1,271 / p 1e-278 | 3.5 EB05 3.3 · IC025 +1.7 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.6 · 93% clinician | no trial data cached |
| Product use in unapproved indication | 487 | 3.4 3.1–3.7ROR 3.5 · χ² 813 / p 4e-179 | 3.3 EB05 3.1 · IC025 +1.6 3/3 methods agree | Reporting / coding artifact | serious PRR 2.9 · 96% clinician | no trial data cached |
| Multiple organ dysfunction syndrome | 461 | 28.3 25.8–30.9ROR 29.3 · χ² 11,911 / p <1e-300 | 27.8 EB05 25.7 · IC025 +4.6 3/3 methods agree | Not in label — unassessed | serious PRR 16.8 · 94% clinician | no trial data cached |
| Sepsis (blood infection) | 445 | 6.7 6.1–7.4ROR 6.9 · χ² 2,171 / p <1e-300 | 6.7 EB05 6.2 · IC025 +2.6 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 4.1 · 92% clinician | no trial data cached |
| Acute kidney injury (sudden kidney damage) | 436 | 4.8 4.4–5.3ROR 5.0 · χ² 1,326 / p 1e-290 | 4.8 EB05 4.4 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 2.9 · 94% clinician | no trial data cached |
| Febrile neutropenia | 431 | 11.0 10.0–12.1ROR 11.4 · χ² 3,904 / p <1e-300 | 10.9 EB05 10.1 · IC025 +3.3 3/3 methods agree | Labeled (related wording) related wording | serious PRR 6.6 · 93% clinician | no trial data cached |
| Neutropenia (low neutrophils (infection-fighting cells)) | 402 | 5.0 4.5–5.5ROR 5.1 · χ² 1,290 / p 1e-282 | 5.0 EB05 4.6 · IC025 +2.1 3/3 methods agree | Labeled (related wording) related wording | serious PRR 3.1 · 94% clinician | no trial data cached |
| Pneumonia (lung infection) | 389 | 2.0 1.8–2.2ROR 2.1 · χ² 204 / p 1e-46 | 2.0 EB05 1.9 · IC025 +0.8 | Labeled adverse reaction exact term | serious PRR 1.3 · 91% clinician | no trial data cached |
| Respiratory failure | 377 | 8.7 7.9–9.7ROR 9.0 · χ² 2,571 / p <1e-300 | 8.6 EB05 7.9 · IC025 +2.9 3/3 methods agree | Labeled adverse reaction exact term | serious PRR 5.2 · 96% clinician | no trial data cached |
| Septic shock | 376 | 14.8 13.4–16.3ROR 15.2 · χ² 4,779 / p <1e-300 | 14.6 EB05 13.4 · IC025 +3.7 3/3 methods agree | Not in label — unassessed | serious PRR 8.8 · 95% clinician | no trial data cached |
| Drug interaction | 345 | 3.7 3.3–4.1ROR 3.7 · χ² 670 / p 5e-148 | 3.6 EB05 3.3 · IC025 +1.7 3/3 methods agree | Reporting / coding artifact | serious PRR 2.4 · 98% clinician | no trial data cached |
| Aspergillus infection | 344 | 94.3 84.7–105.0ROR 97.0 · χ² 29,972 / p <1e-300 | 88.9 EB05 81.3 · IC025 +6.1 3/3 methods agree | Likely indication confounding term in indications | serious n=344 · 95% clinician | 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.
- Vena cava injury — n=23, PRR 587.5
- Protothecosis — n=21, PRR 484.2
- Choroiditis — n=72, PRR 399.8
- Foetal anaemia — n=25, PRR 395.3
- Fungal endocarditis — n=46, PRR 313.0
- Disseminated mucormycosis — n=58, PRR 296.3
- Rhinocerebral mucormycosis — n=48, PRR 274.8
- Disseminated coccidioidomycosis — n=20, PRR 274.4
- Fusarium infection — n=89, PRR 252.2
- Osteomyelitis fungal — n=20, PRR 246.0
✓ 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?
In FDA FAERS, the most frequently co-reported reaction terms for Amphotericin B are pyrexia, multiple organ dysfunction syndrome, sepsis, acute kidney injury, febrile neutropenia, neutropenia. 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 have an FDA boxed warning?
No. The FDA label retrieved for Amphotericin B has no boxed warning; see the label's Warnings and Precautions for the recognised risks.
Do FAERS signals prove that Amphotericin B 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 2b2f3ff5-9d62-4ad2-8eac-1181e5911513, effective 20250603; matched on
openfda.generic_name.exact:"AMPHOTERICIN B") - 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, 1,051 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.