What the label lists and what reports show

Amifostine side effects

Amifostine's FDA label: “Most common adverse reactions are hypotension, nausea and vomiting.” FAERS holds 807 reports naming it through July 30, 2026; the reaction reported most often, leaving out the conditions it is used for, product-use terms and outcomes, is pyrexia (159 reports).

No generic listed

Check it at the source: the amifostine FDA label on DailyMed (effective March 3, 2026, Legacy Pharma USA Inc.); the FDA FAERS public dashboard.

What does the label list?

From the label: adverse reactions
Most common adverse reactions are hypotension, nausea and vomiting.

From the label: adverse reactions, continued
The following serious adverse reactions are discussed in greater detail in other sections of the labeling: – Hypotension and Cardiovascular Events [see Warnings and Precautions (5.3) ] – Severe Cutaneous Reactions [see Warnings and Precautions (5.4) ] – Hypersensitivity [see Warnings and Precautions (5.5) ] – Nausea and Vomiting [see Warnings and Precautions (5.6) ] – Hypocalcemia [see Warnings and Precautions (5.7) ] Most common adverse reactions are hypotension, nausea and vomiting. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Legacy Pharma Inc. at 1-800-727-7151 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trial Experience Because clinical trials are conducted under widely varying conditions, adverse reaction rates observed in the clinical trials of a drug cannot be directly compared to rates in the clinical trials of another drug and may not reflect the rates observed in practice. ETHYOL was administered to patients receiving chemotherapeutic agents for advanced ovarian cancer (WR-1 study) or who were receiving standard fractionated radiotherapy for head and neck cancer (WR-38 study) [see Clinical Studies (14) ]. In the WR-38 study of patients with head and neck cancer, 17% (26/150) discontinued ETHYOL due to adverse reactions. All but one of these patients continued to receive radiation treatment until completion. …

Source: FDA drug label, Legacy Pharma USA Inc., effective March 3, 2026 (SPL set a17563f2-d231-4385-bc94-0217be78b89d), via openFDA; the full label on DailyMed

What do FAERS reports show?

807 reports list amifostine among the medicines taken, each a report of something that happened, not proof the medicine caused it; 86 are coded as a death and 440 as a hospital stay. Counts follow how widely a medicine is used and watched, and they are not a measure of how risky it is. Of the 25 reactions below, 11 are named by the same term (in US spelling) in the label's adverse reactions, warnings or patient leaflet; a reaction the label does not name may still be there under another word, and a report does not show that the medicine caused it.

Reports received each year

The 25 most reported reactions

Pyrexia (named in the label)159
Nausea (named in the label)142
Vomiting (named in the label)115
Hypotension (named in the label)110
Mucosal Inflammation91
Chills (named in the label)69
Dehydration69
Rash (named in the label)66
Pruritus (named in the label)57
Rash Generalised51
Thrombocytopenia51
Dyspnoea (named in the label)50
Malaise (named in the label)46
Injection Site Erythema44
Diarrhoea (named in the label)43
Anaemia41
Pharyngolaryngeal Pain40
Asthenia38
Febrile Neutropenia36
Sepsis36
White Blood Cell Count Decreased36
Neutropenia35
Erythema (named in the label)34
Fatigue32
Rash Maculo-Papular31

Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms

What next?

Amifostine: the full record: label, generics, price, shortages, recalls
Report a side effect to the FDA: MedWatch
Side effects hub: the most reported medicines and reactions