Amifostine side effects: what 807 FDA adverse event reports show

Amifostine · Ethyol · 49 reaction terms · 1,035 drug–reaction co-reports · data 2026-09-14

Drug class

Cytoprotective agent

FDA label, Indications wording

Brand names

Ethyol

openFDA label

Who reports

807 reports · 90% serious · 86 with death outcome · 36% female

openFDA FAERS counts, all years, deduplication not applied

Used for

ETHYOL is a cytoprotective agent indicated for: – reduction of cumulative renal toxicity associated with repeated administration of cisplatin in patients with advanced ovarian cancer. ( 1.1 ) – reduction of the incidence of moderate to severe xerostomia in patients undergoing post-operative radiation treatment for head and neck cancer, where the radiation port includes a substantial portion of the parotid glands.

FDA label, Indications and Usage

What it is

ETHYOL (amifostine) is an organic thiophosphate cytoprotective agent known chemically as 2-[(3-aminopropyl)amino]ethanethiol dihydrogen phosphate (ester) and has the following structural formula: Amifostine is a white crystalline powder which is freely soluble in water.

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 25 strongest signals

Labeled adverse reaction 6Labeled (related wording) 5Lab value / disease marker 1Not in label — unassessed 13

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.
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. 24 further terms are in the interactive explorer. Reaction links open the term's cross-drug page.

Show: hide coding/lab/outcome terms hide indication terms unlabeled only hide PRR-only

Reaction	Reports	PRR 95% CI · ROR · χ²/p	EBGM EB05 · IC025	Label screen	Serious-only & strata	Trial cross-check
Mucosal inflammation	91	91.0 75.0–110.5ROR 102.5 · χ² 7,996 / p <1e-300	89.1 EB05 74.7 · IC025 +5.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 59.9 · 94% clinician	no trial data cached
Rash generalised	51	50.6 38.7–66.0ROR 53.9 · χ² 2,426 / p <1e-300	49.6 EB05 39.2 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 51.9 · 98% clinician	no trial data cached
Toxic epidermal necrolysis (severe skin peeling reaction)	22	38.0 25.1–57.3ROR 39.0 · χ² 755 / p 2e-166	36.8 EB05 25.6 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 23.2 · ♀ 5% (drug 36%)	no trial data cached
Rash maculo-papular	31	36.4 25.8–51.4ROR 37.8 · χ² 1,032 / p 1e-226	35.6 EB05 26.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 15.0 · 96% clinician	no trial data cached
Pharyngitis	17	35.5 22.2–56.8ROR 36.2 · χ² 536 / p 9e-119	34.2 EB05 22.6 · IC025 +3.3 3/3 methods agree	Not in label — unassessed	serious PRR 29.5	no trial data cached
Drug toxicity	18	33.9 21.5–53.5ROR 34.6 · χ² 542 / p 4e-120	32.8 EB05 21.9 · IC025 +3.4 3/3 methods agree	Labeled (related wording) related wording	serious PRR 17.6	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	27	31.5 21.8–45.7ROR 32.6 · χ² 768 / p 3e-169	30.9 EB05 22.3 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.9	no trial data cached
Dermatitis	24	30.1 20.3–44.7ROR 31.0 · χ² 647 / p 5e-143	29.5 EB05 20.8 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 36.0 · 100% clinician	no trial data cached
Anorexia	14	27.9 16.6–46.8ROR 28.3 · χ² 336 / p 2e-75	26.9 EB05 17.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 23.5	no trial data cached
Rash papular	24	27.8 18.7–41.2ROR 28.6 · χ² 593 / p 2e-131	27.2 EB05 19.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 41.0 · 100% clinician	no trial data cached
Injection site rash	23	19.7 13.2–29.5ROR 20.3 · χ² 390 / p 4e-87	19.4 EB05 13.5 · IC025 +3.1 3/3 methods agree	Labeled (related wording) related wording	serious n=21 · ♀ 65% (drug 36%) · 95% clinician	no trial data cached
Hypocalcaemia (low calcium)	12	16.5 9.4–29.0ROR 16.8 · χ² 160 / p 6e-37	15.4 EB05 8.5 · IC025 +2.4 3/3 methods agree	Not in label — unassessed	serious PRR 10.3	no trial data cached
Rash erythematous	28	15.5 10.8–22.4ROR 16.1 · χ² 367 / p 4e-82	15.2 EB05 10.8 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 18.1	no trial data cached
Chills	69	15.3 12.2–19.1ROR 16.6 · χ² 911 / p 2e-200	15.2 EB05 12.4 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.8 · 97% clinician	no trial data cached
Hypotension (low blood pressure)	110	14.3 12.0–17.0ROR 16.4 · χ² 1,357 / p 2e-297	14.2 EB05 12.1 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.3 · 97% clinician	no trial data cached
Febrile neutropenia	36	14.1 10.3–19.4ROR 14.7 · χ² 427 / p 3e-95	13.8 EB05 10.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.6 · 100% clinician	no trial data cached
Dehydration	69	13.4 10.7–16.9ROR 14.6 · χ² 787 / p 2e-173	13.3 EB05 10.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.7 · 95% clinician	no trial data cached
Rash pruritic	25	12.0 8.2–17.7ROR 12.4 · χ² 243 / p 5e-55	11.4 EB05 7.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 14.0 · 100% clinician	no trial data cached
Leukopenia (low white blood cells)	23	12.0 8.0–17.9ROR 12.3 · χ² 221 / p 3e-50	11.3 EB05 7.5 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 7.3	no trial data cached
Rash macular	16	11.9 7.4–19.4ROR 12.2 · χ² 150 / p 9e-35	10.8 EB05 6.5 · IC025 +2.3 3/3 methods agree	Not in label — unassessed	serious PRR 13.0	no trial data cached
Thrombocytopenia (low platelets)	51	11.9 9.1–15.5ROR 12.6 · χ² 500 / p 4e-111	11.6 EB05 9.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.6 · 100% clinician	no trial data cached
Injection site reaction	30	11.4 8.0–16.1ROR 11.8 · χ² 274 / p 7e-62	10.8 EB05 7.7 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 36.4 · 100% clinician	no trial data cached
Neutrophil count decreased	15	9.6 5.8–15.9ROR 9.8 · χ² 108 / p 2e-25	8.2 EB05 5.0 · IC025 +2.0 3/3 methods agree	Lab value / disease marker	serious PRR 7.2	no trial data cached
Injection site erythema (redness where injected)	45	9.5 7.1–12.6ROR 10.0 · χ² 335 / p 5e-75	9.0 EB05 6.9 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 33.1 · 95% clinician	no trial data cached
Skin burning sensation	12	4.4 2.5–7.7ROR 4.4 · χ² 28 / p 6e-8	3.8 EB05 2.4 · IC025 +1.0 3/3 methods agree	Not in label — unassessed	serious PRR 21.7	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
Hypotension (low blood pressure)	110	14.3 12.0–17.0ROR 16.4 · χ² 1,357 / p 2e-297	14.2 EB05 12.1 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 10.3 · 97% clinician	no trial data cached
Mucosal inflammation	91	91.0 75.0–110.5ROR 102.5 · χ² 7,996 / p <1e-300	89.1 EB05 74.7 · IC025 +5.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 59.9 · 94% clinician	no trial data cached
Dehydration	69	13.4 10.7–16.9ROR 14.6 · χ² 787 / p 2e-173	13.3 EB05 10.8 · IC025 +3.2 3/3 methods agree	Not in label — unassessed	serious PRR 9.7 · 95% clinician	no trial data cached
Chills	69	15.3 12.2–19.1ROR 16.6 · χ² 911 / p 2e-200	15.2 EB05 12.4 · IC025 +3.4 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 14.8 · 97% clinician	no trial data cached
Thrombocytopenia (low platelets)	51	11.9 9.1–15.5ROR 12.6 · χ² 500 / p 4e-111	11.6 EB05 9.0 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 7.6 · 100% clinician	no trial data cached
Rash generalised	51	50.6 38.7–66.0ROR 53.9 · χ² 2,426 / p <1e-300	49.6 EB05 39.2 · IC025 +4.6 3/3 methods agree	Not in label — unassessed	serious PRR 51.9 · 98% clinician	no trial data cached
Injection site erythema (redness where injected)	45	9.5 7.1–12.6ROR 10.0 · χ² 335 / p 5e-75	9.0 EB05 6.9 · IC025 +2.6 3/3 methods agree	Labeled (related wording) related wording	serious PRR 33.1 · 95% clinician	no trial data cached
Febrile neutropenia	36	14.1 10.3–19.4ROR 14.7 · χ² 427 / p 3e-95	13.8 EB05 10.3 · IC025 +3.0 3/3 methods agree	Not in label — unassessed	serious PRR 8.6 · 100% clinician	no trial data cached
Rash maculo-papular	31	36.4 25.8–51.4ROR 37.8 · χ² 1,032 / p 1e-226	35.6 EB05 26.3 · IC025 +3.9 3/3 methods agree	Not in label — unassessed	serious PRR 15.0 · 96% clinician	no trial data cached
Injection site reaction	30	11.4 8.0–16.1ROR 11.8 · χ² 274 / p 7e-62	10.8 EB05 7.7 · IC025 +2.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 36.4 · 100% clinician	no trial data cached
Rash erythematous	28	15.5 10.8–22.4ROR 16.1 · χ² 367 / p 4e-82	15.2 EB05 10.8 · IC025 +3.0 3/3 methods agree	Labeled (related wording) related wording	serious PRR 18.1	no trial data cached
Stevens-johnson syndrome (severe blistering skin reaction)	27	31.5 21.8–45.7ROR 32.6 · χ² 768 / p 3e-169	30.9 EB05 22.3 · IC025 +3.7 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 18.9	no trial data cached
Rash pruritic	25	12.0 8.2–17.7ROR 12.4 · χ² 243 / p 5e-55	11.4 EB05 7.8 · IC025 +2.6 3/3 methods agree	Not in label — unassessed	serious PRR 14.0 · 100% clinician	no trial data cached
Rash papular	24	27.8 18.7–41.2ROR 28.6 · χ² 593 / p 2e-131	27.2 EB05 19.2 · IC025 +3.5 3/3 methods agree	Not in label — unassessed	serious PRR 41.0 · 100% clinician	no trial data cached
Dermatitis	24	30.1 20.3–44.7ROR 31.0 · χ² 647 / p 5e-143	29.5 EB05 20.8 · IC025 +3.6 3/3 methods agree	Labeled adverse reaction exact term	serious PRR 36.0 · 100% 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.

Rash generalised — n=51, PRR 50.6
Rash maculo-papular — n=31, PRR 36.4
Rash papular — n=24, PRR 27.8
Febrile neutropenia — n=36, PRR 14.1
Dehydration — n=69, PRR 13.4
Rash pruritic — n=25, PRR 12.0
Leukopenia — n=23, PRR 12.0
Thrombocytopenia — n=51, PRR 11.9

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 Amifostine?

In FDA FAERS, the most frequently co-reported reaction terms for Amifostine are hypotension, mucosal inflammation, dehydration, chills, thrombocytopenia, rash generalised. 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 Amifostine have an FDA boxed warning?

No. The FDA label retrieved for Amifostine has no boxed warning; see the label's Warnings and Precautions for the recognised risks.

Do FAERS signals prove that Amifostine 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 a17563f2-d231-4385-bc94-0217be78b89d, effective 20260303; matched on openfda.generic_name.exact:"AMIFOSTINE")
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, field patient.drug.openfda.generic_name.exact, 49 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.