What the label lists and what reports show
Velaglucerase alfa side effects
Velaglucerase alfa's FDA label: “Most common adverse reactions (≥10%) are: hypersensitivity reactions, headache, dizziness, abdominal pain, nausea, back pain, joint pain, prolonged activated PTT, fatigue/asthenia, and pyrexia ( 6.1 ).” FAERS holds 2,049 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 covid-19 (167 reports).
- No generic listed
- Boxed warning
Check it at the source: the velaglucerase alfa FDA label on DailyMed (effective November 26, 2024, Takeda Pharmaceuticals America, Inc.); the FDA FAERS public dashboard.
What does the label list?
From the label: adverse reactionsMost common adverse reactions (≥10%) are: hypersensitivity reactions, headache, dizziness, abdominal pain, nausea, back pain, joint pain, prolonged activated PTT, fatigue/asthenia, and pyrexia ( 6.1 ).
Table 1: Adverse Reactions Observed in ≥10% of Adult and Pediatric Patients with Type 1 Gaucher Disease Treated with VPRIV in the Pooled 5 Clinical Studies
| Adverse Reaction | Naïve to ERT N = 54 Number of patients (%) | Switched from imiglucerase to VPRIV N = 40 Number of patients (%) |
|---|---|---|
| Hypersensitivity reaction Denotes any event considered related to and occurring within up… | 28 (52) | 9 (23) |
| Headache | 19 (35) | 12 (30) |
| Dizziness | 12 (22) | 3 (8) |
| Pyrexia | 12 (22) | 5 (13) |
| Abdominal pain | 10 (19) | 6 (15) |
| Back pain | 9 (17) | 7 (18) |
| Joint pain (knee) | 8 (15) | 3 (8) |
| Asthenia/Fatigue | 8 (15) | 5 (13) |
| Activated partial thromboplastin time prolonged | 6 (11) | 2 (5) |
| Nausea | 3 (6) | 4 (10) |
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 (≥10%) are: hypersensitivity reactions, headache, dizziness, abdominal pain, nausea, back pain, joint pain, prolonged activated PTT, fatigue/asthenia, and pyrexia ( 6.1 ). To report SUSPECTED ADVERSE REACTIONS, contact Takeda Pharmaceuticals at 1-800-828-2088 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. The data described below reflect exposure of 94 patients with type 1 Gaucher disease who received VPRIV at doses ranging from 15 Units/kg to 60 Units/kg every other week in 5 clinical studies. Fifty-four (54) patients were naïve to enzyme replacement therapy (ERT) and received VPRIV for 9 months and 40 patients switched from imiglucerase to VPRIV treatment and received VPRIV for 12 months [see Clinical Studies (14) ]. Patients were between 4 and 71 years old at time of first treatment with VPRIV, and included 46 male and 48 female patients. The most serious adverse reactions in patients treated with VPRIV were hypersensitivity reactions [see Warnings and Precautions (5.1) ]. …
Source: FDA drug label, BLA022575 (Shire Human Genetic), as published by Takeda Pharmaceuticals America, Inc., effective November 26, 2024 (SPL set ca02f7a4-ae4f-43c1-a06a-259fe4fcf9cf), via openFDA; the full label on DailyMed
What do FAERS reports show?
2,049 reports list velaglucerase alfa among the medicines taken, each a report of something that happened, not proof the medicine caused it; 279 are coded as a death and 879 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, 8 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?
- Velaglucerase alfa: 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