What the label lists and what reports show
Glucarpidase side effects
Glucarpidase's FDA label: “The most common related adverse events (>1%) were paresthesia, flushing, nausea and/or vomiting, hypotension and headache.” FAERS holds 358 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 laboratory test interference (58 reports).
- No generic listed
Check it at the source: the glucarpidase FDA label on DailyMed (effective November 27, 2024, BTG International Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsThe most common related adverse events (>1%) were paresthesia, flushing, nausea and/or vomiting, hypotension and headache.
Table 1: Select Adverse Reactions Occurring in Patients Receiving VORAXAZE in Study 1 and Study 2
| Adverse Reaction | 1 This incidence includes the following terms: flushing, feeling hot, burning sensation.… VORAXAZE N= 290 Grades 1 and 2 2 (%) |
|---|---|
| Paresthesia | 2 |
| Flushing 1,2 | 2 |
| Nausea/Vomiting | 2 |
| Headache | 1 |
| Hypotension | 1 |
| Blurred Vision | <1 |
| Diarrhea | <1 |
| Hypersensitivity | <1 |
| Hypertension | <1 |
| Rash | <1 |
| Throat irritation/Throat tightness | <1 |
| Tremor | <1 |
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 clinically significant adverse reactions are described elsewhere in the labeling: Serious Hypersensitivity Reactions [Warnings and Precautions ( 5.1 )]. The most common related adverse events (>1%) were paresthesia, flushing, nausea and/or vomiting, hypotension and headache. ( 6 ) To report SUSPECTED ADVERSE REACTIONS, contact BTG at 877-377-3784 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch. 6.1 Clinical Trials Experience Because clinical trials are conducted under controlled but widely varying conditions, adverse reaction rates observed in clinical trials of VORAXAZE cannot be directly compared to rates in the clinical trials of other drugs and may not reflect the rates observed in practice. The evaluation of adverse reactions in patients who received VORAXAZE was confounded, because patients had toxic plasma methotrexate concentration due to prolonged methotrexate clearance, which is associated with myelosuppression, mucositis, acute hepatitis, and renal dysfunction and failure. The safety of VORAXAZE is based on data from 290 patients who were enrolled in Study 1 or Study 2, two single-arm, open-label, multicenter studies conducted in patients who had markedly delayed methotrexate clearance due to impaired renal function.
Source: FDA drug label, BTG International Inc., effective November 27, 2024 (SPL set acaef5a6-b740-40e3-8ffe-74a75c74745c), via openFDA; the full label on DailyMed
What do FAERS reports show?
358 reports list glucarpidase among the medicines taken, each a report of something that happened, not proof the medicine caused it; 70 are coded as a death and 84 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 19 reactions below, none is 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?
- Glucarpidase: 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