What the label lists and what reports show
Palifermin side effects
Palifermin's FDA label: “Most common adverse reactions (incidence ≥20% and 5%≥placebo) are rash, fever, elevated serum amylase, pruritus, erythema, and edema ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Swedish Orphan Biovitrum at 1-866-773-5274 or FDA at 1-800-FDA-1088 or …” FAERS holds 389 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 mucosal inflammation (56 reports).
- No generic listed
Check it at the source: the palifermin FDA label on DailyMed (effective December 17, 2025, Swedish Orphan Biovitrum AB (publ)); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥20% and 5%≥placebo) are rash, fever, elevated serum amylase, pruritus, erythema, and edema ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Swedish Orphan Biovitrum at 1-866-773-5274 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
Table 1. Incidence of Adverse Reactions Occurring with a Between-Group Difference of ≥ 5%
| BODY SYSTEM Adverse Reaction | Kepivance (n = 409) % | Placebo (n = 241) % |
|---|---|---|
| Edema | 28 | 21 |
| Pain | 16 | 11 |
| Fever | 39 | 34 |
| Mouth/Tongue Thickness or Discoloration | 17 | 8 |
| Arthralgia | 10 | 5 |
| Rash | 62 | 50 |
| Pruritus | 35 | 24 |
| Erythema | 32 | 22 |
| Taste Altered | 16 | 8 |
| Dysesthesia – Hyperesthesia / hypoesthesia/ paresthesia | 12 | 7 |
| All grades | 28 | 23 |
| Grade 3 and 4 | 11 | 5 |
| All grades | 62 | 54 |
| Grade 3 and 4 | 38 | 31 |
Rows and numbers as the label prints them, under its own column headings (the first rows of a longer table where it runs on). A reaction in a trial table is not necessarily caused by the medicine, and trials differ from everyday use.
From the label: adverse reactions, continuedMost common adverse reactions (incidence ≥20% and 5%≥placebo) are rash, fever, elevated serum amylase, pruritus, erythema, and edema ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact Swedish Orphan Biovitrum at 1-866-773-5274 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 clinical practice. The data described in Table 1 and the discussion below reflect exposure to Kepivance in 409 patients with hematologic malignancies who were enrolled in 3 randomized, placebo-controlled clinical trials and a pharmacokinetic study. Patients received Kepivance either before, or before and after, regimens of myelotoxic chemotherapy, with or without total body irradiation (TBI), followed by hematopoietic stem cell support. Kepivance was administered in daily doses ranging from 5 to 80 mcg/kg/day. The total dose of Kepivance ranged from 15 to 480 mcg/kg with a median of 360 mcg/kg. The population had a median age of 48 years (range: 41 to 60 years), 62% were male and 83% were White with 7.4 % Black and 6.2 % Hispanic. …
Source: FDA drug label, Swedish Orphan Biovitrum AB (publ), effective December 17, 2025 (SPL set 426f6e64-2c20-4a61-6d65-7320426f6e64), via openFDA; the full label on DailyMed
What do FAERS reports show?
389 reports list palifermin among the medicines taken, each a report of something that happened, not proof the medicine caused it; 67 are coded as a death and 153 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 23 reactions below, 4 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.
The 25 most reported reactions
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Palifermin: 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