What the label lists and what reports show
Tagraxofusp side effects
Tagraxofusp's FDA label: “Most common adverse reactions (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase.” FAERS holds 520 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 capillary leak syndrome (124 reports).
- No generic listed
- Boxed warning
Check it at the source: the tagraxofusp FDA label on DailyMed (effective December 9, 2024); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase.
Table 3. Adverse Reactions in ≥ 10% of Patients Receiving 12 mcg/kg of ELZONRIS
| Reaction | All Grades % | Grade ≥ 3 % |
|---|---|---|
| Capillary leak syndrome 1 | 53 | 11 |
| Hypotension | 25 | 7 |
| Hypertension | 14 | 6 |
| Fatigue | 45 | 7 |
| Pyrexia | 43 | 0 |
| Peripheral edema | 39 | 1 |
| Chills | 26 | 1 |
| Nausea | 45 | 0 |
| Constipation | 24 | 0 |
| Diarrhea | 21 | 0 |
| Vomiting | 19 | 0 |
| Weight increase | 31 | 0 |
| Headache | 28 | 0 |
| Dizziness | 21 | 0 |
| Decreased appetite | 22 | 0 |
| Dyspnea | 20 | 3 |
| Epistaxis | 12 | 1 |
| Cough | 12 | 0 |
| Febrile neutropenia | 19 | 16 |
| Back pain | 19 | 2 |
| Pain in extremity | 10 | 2 |
| Tachycardia | 17 | 0 |
| Insomnia | 16 | 0 |
| Anxiety | 15 | 0 |
| Pruritus | 10 | 0 |
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, continuedThe following serious adverse drug reactions are described elsewhere in the labeling: Capillary Leak Syndrome [see Warnings and Precautions ( 5.1 ) ] Hypersensitivity Reactions [see Warnings and Precautions ( 5.2 ) ] Hepatotoxicity [see Warnings and Precautions ( 5.3 ) ] Most common adverse reactions (incidence ≥ 30%) are capillary leak syndrome, nausea, fatigue, pyrexia, peripheral edema, and weight increase. Most common laboratory abnormalities (incidence ≥ 50%) are decreases in albumin, platelets, hemoglobin, calcium, and sodium, and increases in glucose, ALT and AST. ( 6.1 ) To report SUSPECTED ADVERSE REACTIONS, contact Stemline Therapeutics, Inc. at 1-877-332-7961 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials 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. Safety of ELZONRIS was assessed in a single-arm clinical trial that included 122 adults with newly diagnosed or relapsed/refractory myeloid malignancies, including 86 with BPDCN, treated with ELZONRIS 12 mcg/kg daily for 5 days of a 21-day cycle. The overall median number of cycles started was 2.5 (range, 1-76), and 4 in patients with BPDCN (range, 1-76). …
Source: FDA drug label, Stemline Therapeutics, Inc., effective December 9, 2024 (SPL set 80eb1080-fe20-4af0-b2a5-a67999923fa8), via openFDA; the full label on DailyMed
What do FAERS reports show?
520 reports list tagraxofusp among the medicines taken, each a report of something that happened, not proof the medicine caused it; 156 are coded as a death and 132 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 21 reactions below, 7 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
Source: FDA Adverse Event Reporting System (FAERS) via openFDA, reports through July 30, 2026; reactions as MedDRA preferred terms
What next?
- Tagraxofusp: 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